EP1620020B1 - Left atrial appendage occlusion device with active expansion - Google Patents
Left atrial appendage occlusion device with active expansion Download PDFInfo
- Publication number
- EP1620020B1 EP1620020B1 EP04750428A EP04750428A EP1620020B1 EP 1620020 B1 EP1620020 B1 EP 1620020B1 EP 04750428 A EP04750428 A EP 04750428A EP 04750428 A EP04750428 A EP 04750428A EP 1620020 B1 EP1620020 B1 EP 1620020B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- implant
- distal end
- distal
- proximal
- occlusion device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Definitions
- Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability. There are over 700,000 strokes per year in the United States alone. Of these, roughly 100,000 are hemoragic, and 600,000 are ischemic (either due to vessel narrowing or to embolism). The most common cause of embolic stroke emanating from the heart is thrombus formation due to atrial fibrillation. Approximately 80,000 strokes per year are attributable to atrial fibrillation. Atrial fibrillation is an arrhythmia of the heart that results in a rapid and chaotic heartbeat that produces lower cardiac output and irregular and turbulent blood flow in the vascular system. There are over five million people worldwide with atrial fibrillation, with about four hundred thousand new cases reported each year. Atrial fibrillation is associated with a 500 percent greater risk of stroke due to the condition. A patient with atrial fibrillation typically has a significantly decreased quality of life due, in part, to the fear of a stroke, and the pharmaceutical regimen necessary to reduce that risk.
- LAA left atrial appendage
- the LAA is a cavity which looks like a small finger or windsock and which is connected to the lateral wall of the left atrium between the mitral valve and the root of the left pulmonary vein.
- the LAA normally contracts with the rest of the left atrium during a normal heart cycle, thus keeping blood from becoming stagnant therein, but often fails to contract with any vigor in patients experiencing atrial fibrillation due to the discoordinate electrical signals associated with AF.
- thrombus formation is predisposed to form in the stagnant blood within the LAA.
- US 6,290,674 discloses a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart.
- the closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. It is also disclosed that the distal end of the closure catheter may be provided with one or more anchor supports for removably carrying one or more tissue anchors.
- US 6,371,971 discloses a filter system for temporary placement of a filter in an artery or vein.
- the filter system includes a guidewire that is first positioned across a lesion within a vessel.
- the guidewire may include a distal stop.
- a slideable filter is then advanced along the guidewire using an advancing mechanism, typically an elongate member slideable over the guidewire and contacting the filter.
- a capture sheath may be disposed about the filter during advancement. Once the filter is positioned downstream of the lesion, the capture sheath is withdrawn, allowing the filter to expand. Further distal advancement of the filter is prohibited by the stop. After expansion of the filter, the capture sheath and the advancing mechanism are withdrawn from the region of interest, and removed from the patient's vessel. The filter may then be retrieved using a capture sheath or exchanged for a second filter after removing the first filter.
- FIGS. 1 and 2 there is illustrated one occlusion device 10.
- the occlusion device 10 comprises an occluding member 11 comprising a frame 14 and a barrier 15.
- the frame 14 comprises a plurality of radially outwardly extending spokes 17 each having a length within the range of from about 0.5 cm to about 2 cm from a hub 16.
- the spokes have an axial length of about 1.5 cm.
- anywhere within the range of from about 3 spokes to about 40 spokes may be utilized. In some embodiments, anywhere from about 12 to about 24 spokes are utilized, and, 18 spokes are utilized in one example.
- the spokes are advanceable from a generally axially extending orientation such as to fit within a tubular introduction catheter to a radially inclined orientation as illustrated in FIG. 1 and FIG. 2 following deployment from the catheter.
- the spokes are biased radially outwardly such that the occlusion member expands to its enlarged, implantation cross-section under its own bias following deployment from the catheter.
- the occlusion member may be enlarged using any of a variety of enlargement structures such as an inflatable balloon, or a catheter for axially shortening the occlusion member, as is discussed further below.
- the spokes comprise a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art.
- Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique.
- rectangular cross section spokes are cut such as by known laser cutting techniques from tube stock, a portion of which forms the hub 16.
- the barrier 15 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for barrier 15 can be determined through routine experimentation by those of skill in the art.
- the barrier 15 may be provided on either one or both axially facing sides of the occlusion member.
- the barrier 15 comprises two layers, with one layer on each side of the frame 14. The two layers may be bonded to each other around the spokes 17 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein.
- the barrier 15 preferably has a thickness of no more than about 0.003" and a porosity within the range of from about 5 ⁇ m to about 60 ⁇ m.
- the barrier 15 in one example preferably is securely attached to the frame 14 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment.
- a bonding layer 254 preferably comprises a mesh or other porous structure having an open surface area within the range of from about 10% to about 90%.
- the open surface area of the mesh is within the range of from about 30% to about 60%.
- the opening or pore size of the bonding layer 254 is preferably within the range of from about 0,013 cm (0.005 inches) to about 0,13 cm (0.050 inches) and, in one embodiment, is about 0,05 cm (0.020 inches).
- the thickness of the bonding layer 254 can be varied widely, and is generally within the range of from about 0,0013 cm (0.0005 inches) to about 0,013 cm (0.005 inches). In an example, the bonding layer 254 has a thickness of about 0,0025 cm to 0,0050 cm (0.001 to about 0.002 inches).
- One suitable polyethylene bonding mesh is available from Smith and Nephew, under the code SN9.
- the bonding layer 254 is preferably placed adjacent one or both sides of a spoke or other frame element 14.
- the bonding layer 254 and frame 14 layers are then positioned in-between a first membrane 250 and a second membrane 252 to provide a composite membrane stack.
- the first membrane 250 and second membrane 252 may comprise any of a variety of materials and thicknesses, depending upon the desired functional result.
- the membrane has a thickness within the range of from about 0,0013 cm to 0,0254 cm (0.0005 inches to about 0.010 inches).
- the membranes 250 and 252 each have a thickness on the order of from about 0,0025 cm to 0,0050 cm (0.001 inches to about 0.002 inches), and comprise porous ePTFE, having a porosity within the range of from about 10 microns to about 100 microns.
- the composite stack is heated to a temperature of from about 200° F to about 300° F, for about 1 minute to about 5 minutes under pressure to provide a finished composite membrane assembly with an embedded frame 14 as illustrated schematically in Figure 15 .
- the final composite membrane has a thickness within the range of from about 0,0025 to 0,025 cm (0.001 inches to about 0.010 inches), and, preferably, is about 0,0050 to 0,008 cm (0.002 to about 0.003 inches) in thickness.
- the thicknesses and process parameters of the foregoing may be varied considerably, depending upon the materials of the bonding layer 254 the first layer 250 and the second layer 252.
- the resulting finished composite membrane has a plurality of "unbonded" windows or areas 256 suitable for cellular attachment and/or ingrowth.
- the attachment areas 256 are bounded by the frame 14 struts, and the cross-hatch or other wall pattern formed by the bonding layer 254.
- a regular window 256 pattern is produced in the bonding layer 254.
- the foregoing procedure allows the bonding mesh to flow into the first and second membranes 250 and 252 and gives the composite membrane 15 greater strength (both tensile and tear strength) than the components without the bonding mesh.
- the composite allows uniform bonding while maintaining porosity of the membrane 15, to facilitate tissue attachment.
- the composite flexibility is preserved and the overall composite layer thickness can be minimized.
- the occlusion device 10 may be further provided with a bulking element or stabilizer 194.
- the stabilizer 194 may be spaced apart along an axis from the occluding member 11.
- a distal end 190 and a proximal end 192 are identified for reference.
- the designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter.
- the stabilizer 194 is spaced distally apart from the occluding member 11.
- the occluding member 11 has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in one embodiment, about 3 cm.
- the axial length of the occluding member 11 in an expanded, unstressed orientation from the distal end 192 to the hub 16 is on the order of about 1 cm.
- the overall length of the occlusion device 10 from the distal end 192 to the proximal end 190 is within the range of from about 1.5 cm to about 4 cm and, in one example, about 2.5 cm.
- the axial length of the stabilizer 194 between distal hub 191 and proximal hub 16 is within the range of from about 0.5 cm to about 2 cm, and, in one embodiment, about 1 cm.
- the expanded diameter of the stabilizer 194 is within the range of from about 0.5 cm to about 2.5 cm, and, in one example, about 1.4 cm.
- the outside diameter of the distal hub 191 and proximal hub A 16 is about 2.5 mm.
- the occlusion device 10 is provided with one or more retention structures for retaining the device in the left atrial appendage or other body cavity or lumen.
- a plurality of barbs or other anchors 195 are provided, for engaging adjacent tissue to retain the occlusion device 10 in its implanted position and to limit relative movement between the tissue and the occlusion device.
- the illustrated anchors are provided on one or more of the spokes 17, or other portion of frame 14.
- every spoke, every second spoke or every third spoke are provided with one or two or more anchors each.
- the illustrated anchor is in the form of a barb, with one on each spoke for extending into tissue at or near the opening of the LAA.
- two or three barbs may alternatively be desired on each spoke.
- each barb is inclined in a proximal direction. This is to inhibit proximal migration of the implant out of the left atrial appendage.
- distal refers to the direction into the left atrial appendage
- proximal refers to the direction from the left atrial appendage into the heart.
- one or more barbs may face distally, to inhibit distal migration of the occlusion device deeper into the LAA.
- the implant may be provided with at least one proximally facing barb and at least one distally facing barb.
- a proximal plurality of barbs may be inclined in a first direction
- a distal plurality of barbs may be inclined in a second direction, to anchor the implant against both proximal and distal migration.
- anchors 195 may also be provided on the stabilizer 194, such that it assists not only in orienting the occlusion device 10 and resisting compression of the LAA, but also in retaining the occlusion device 10 within the LAA.
- Any of a wide variety of structures may be utilized for anchor 195, either on the occluding member 11 or the stabilizer 194 or both, such as hooks, barbs, pins, sutures, adhesives, ingrowth surfaces and others which will be apparent to those of skill in the art in view of the disclosure herein.
- the occlusion device 10 is preferably positioned within a tubular anatomical structure to be occluded such as the left atrial appendage.
- the occluding member 11 is positioned across or near the opening to the LAA and the stabilizer 194 is positioned within the LAA.
- the stabilizer 194 assists in the proper location and orientation of the occluding member 11, as well as resists compression of the LAA behind the occluding member 11.
- the present inventors have determined that following deployment of an occluding member 11 without a stabilizer 194 or other bulking structure to resist compression of the LAA, normal operation of the heart may cause compression and resulting volume changes in the LAA, thereby forcing fluid past the occluding member 11 and inhibiting or preventing a complete seal. Provision of a stabilizer 194 dimensioned to prevent the collapse or pumping of the LAA thus minimizes leakage, and provision of the barbs facilitates endothelialization or other cell growth across the occluding member 11.
- the stabilizer 194 is preferably movable between a reduced cross-sectional profile for transluminal advancement into the left atrial appendage, and an enlarged cross-sectional orientation as illustrated to fill or to substantially fill a cross-section through the LAA.
- the stabilizing member may enlarge to a greater cross section than the (pre-stretched) anatomical cavity, to ensure a tight fit and minimize the likelihood of compression.
- One convenient construction includes a plurality of elements 196 which are radially outwardly expandable in response to axial compression of a distal hub 191 towards a proximal hub 16. Elements 196 each comprise a distal segment 198 and a proximal segment 202 connected by a bend 200.
- the elements 196 may be provided with a bias in the direction of the radially enlarged orientation as illustrated in FIG. 2 , or may be radially expanded by applying an expansion force such as an axially compressive force between distal hub 191 and proximal hub 16 or a radial expansion force such as might be applied by an inflatable balloon.
- Elements 196 may conveniently be formed by laser cutting the same tube stock as utilized to construct the distal hub 191, proximal hub 16 and frame 14, as will be apparent to those of skill in the art in view of the disclosure herein.
- the various components of the occlusion device 10 may be separately fabricated or fabricated in subassemblies and secured together during manufacturing.
- a radiopaque dye or other visualizable media may be introduced on one side or the other of the occlusion device, to permit visualization of any escaped blood or other fluid past the occlusion device.
- the occlusion device may be provided with a central lumen or other capillary tube or aperture which permits introduction of a visualizable dye from the deployment catheter through the occlusion device and into the entrapped space on the distal side of the occlusion device.
- dye may be introduced into the entrapped space distal to the occlusion device such as by advancing a small gauge needle from the deployment catheter through the barrier 15 on the occlusion device, to introduce dye.
- the occlusion device 10 comprises an occlusion member 11 and a stabilizing member 194 as previously discussed.
- each of the distal segments 198 inclines radially outwardly in the proximal direction and terminates in a proximal end 204.
- the proximal end 204 may be provided with an atraumatic configuration, for pressing against, but not penetrating, the wall of the left atrial appendage or other tubular body structure.
- Three or more distal segments 198 are preferably provided, and generally anywhere within the range of from about 6 to about 20 distal segments 198 may be used. In one example, 9 distal segments 198 are provided.
- three of the distal segments 198 have an axial length of about 5 mm, and 6 of the distal segments 198 have an axial length of about 1 cm. Staggering the lengths of the distal segments 198 may axially elongate the zone in the left atrial appendage against which the proximal ends 204 provide anchoring support for the occlusion device.
- the occlusion device 10 illustrated in Figures 3 and 4 is additionally provided with a hinge 206 to allow the longitudinal axis of the occlusion member 11 to be angularly oriented with respect to the longitudinal axis of the stabilizing member 194.
- the hinge 206 is a helical coil, although any of a variety of hinge structures can be utilized.
- the illustrated example may be conveniently formed by laser cutting a helical slot through a section of the tube from which the principal structural components of the occlusion device 10 are formed.
- an annular band 208 connects the hinge 206 to a plurality of axially extending struts 210.
- Axial struts 210 are provided, spaced equilaterally around the circumference of the body.
- Axial struts 210 may be formed from a portion of the wall of the original tube stock, which portion is left in its original axial orientation following formation of the distal segments 198 such as by laser cutting from the tubular wall.
- the occlusion member 11 is provided with a proximal zone 212 on each of the spokes 17.
- Proximal zone 212 has an enhanced degree of flexibility, to accommodate the fit between the occlusion member 11 and the wall of the left atrial appendage.
- Proximal section 212 may be formed by reducing the cross sectional area of each of the spokes 17, which may be provided with a wave pattern as illustrated.
- Proximal point 214 may be contained within layers of the barrier 15, or may extend through or beyond the barrier 15 such as to engage adjacent tissue and assist in retaining the occlusion device 10 at the deployment site.
- the occlusion device 10 is provided with a proximal face 216 on the occlusion member 11, instead of the open and proximally concave face on the embodiment of Figures 1 and 2 .
- the proximal face 216 is formed by providing a proximal spoke 218 which connects at an apex 220 to some or all of the distal spokes 17.
- the proximal spoke 218, and corresponding apex 220 and distal spoke 17 may be an integral structure, such as a single ribbon or wire, or element cut from a tube stock as has been discussed.
- Proximal spokes 218 are each attached to a hub 222 at the proximal end 192 of the occlusion device 10.
- the barrier 15 may surround either the proximal face or the distal face or both on the occlusion member 11.
- provision of a proximal spoke 218 connected by an apex 220 to a distal spoke 17 provides a greater radial force than a distal spoke 17 alone, which will provide an increased resistance to compression if the occlusion member 11 is positioned with the LAA.
- the occlusion device 10 comprises an occluding member but does not include a distinct stabilizing member as has been illustrated in connection with previous example. Any of the example previously disclosed herein may also be constructed using the occluding member only, and omitting the stabilizing member as will be apparent to those of skill in the art in view of the disclosure herein.
- the occluding device 10 comprises a proximal end 192, a distal end 190, and a longitudinal axis extending therebetween.
- a plurality of supports 228 extend between a proximal hub 222 and a distal hub 191. At least two or three supports 228 are provided, and preferably at least about ten. In one embodiment, sixteen supports 228 are provided. However, the precise number of supports 228 can be modified, depending upon the desired physical properties of the occlusion device 10.
- Each support 228 comprises a proximal spoke portion 218, a distal spoke portion 17, and an apex 220 as has been discussed.
- Each of the proximal spoke portion 218, distal spoke portion 17 and apex 220 may be a region on an integral support 228, such as a continuous rib or frame member which extends in a generally curved configuration as illustrated with a concavity facing towards the longitudinal axis of the occlusion device 10. Thus, no distinct point or hinge at apex 220 is necessarily provided.
- each support 228, is provided with one or two or more barbs 195.
- the occlusion device 10 is in its enlarged orientation, such as for occluding a left atrial appendage or other body cavity or lumen.
- each of the barbs 195 projects generally radially outwardly from the longitudinal axis, and is inclined in the proximal direction.
- One or more barbs may also be inclined distally, as is discussed elsewhere herein.
- the barbs 195 and corresponding support 228 are cut from a single ribbon, sheet or tube stock, the barb 195 will incline radially outwardly at approximately a tangent to the curve formed by the support 228.
- the occlusion device 10 constructed from the frame illustrated in Figure 7 may be constructed in any of a variety of ways, as will become apparent to those of skill in the art in view of the disclosure herein.
- the occlusion device 10 is constructed by laser cutting a piece of tube stock to provide a plurality of axially extending slots in-between adjacent supports 228.
- each barb 195 can be laser cut from the corresponding support 228 or space in-between adjacent supports 228.
- the generally axially extending slots which separate adjacent supports 228 end a sufficient distance from each of the proximal end 192 and distal end 190 to leave a proximal hub 222 and a distal hub 191 to which each of the supports 228 will attach.
- an integral cage structure may be formed.
- each of the components of the cage structure may be separately formed and attached together such as through soldering, brazing, heat bonding, adhesives, and other fastening techniques which are known in the art.
- a further method of manufacturing the occlusion device 10 is to laser cut a slot pattern on a flat sheet of appropriate material, such as a flexible metal or polymer, as has been discussed in connection with previous embodiments. The flat sheet may thereafter be rolled about an axis and opposing edges bonded together to form a tubular structure.
- the apex portion 220 which carries the barb 195 may be advanced from a low profile orientation in which each of the supports 228 extend generally parallel to the longitudinal axis, to an implanted orientation as illustrated, in which the apex 220 and the barb 195 are positioned radially outwardly from the longitudinal axis.
- the support 228 may be biased towards the enlarged orientation, or may be advanced to the enlarged orientation under positive force following positioning within the tubular anatomical structure, in any of a variety of manners.
- an inflatable balloon 230 is positioned within the occlusion device 10.
- Inflatable balloon 230 is connected by way of a removable coupling 232 to an inflation catheter 234.
- Inflation catheter 234 is provided with an inflation lumen for providing communication between an inflation media source 236 outside of the patient and the balloon 230.
- the balloon 230 is inflated, thereby engaging barbs 195 with the surrounding tissue.
- the inflation catheter 234 is thereafter removed, by decoupling the removable coupling 232, and the inflation catheter 234 is thereafter removed.
- the balloon 230 may be either left in place within the occlusion device 10, or deflated and removed by the inflation catheter 234.
- the supports 228 are radially enlarged such as through the use of a deployment catheter 238. See FIG. 9 .
- Deployment catheter 238 comprises a lumen for movably receiving a deployment element such as a flexible line 240.
- Deployment line 240 extends in a loop 244 formed by an aperture or slip knot 242.
- proximal retraction on the deployment line 240 while resisting proximal movement of proximal hub 222 such as by using the distal end of the catheter 238 will cause the distal hub 191 to be drawn towards the proximal hub 222, thereby radially enlarging the cross-sectional area of the occlusion device 10.
- the supports 228 will retain the radially enlarged orientation by elastic deformation, or may be retained in the enlarged orientation such as by securing the slip knot 242 immovably to the deployment line 240 at the fully radially enlarged orientation. This may be accomplished in any of a variety of ways, using additional knots, clips, adhesives, or other techniques known in the art.
- a pullwire 240 may be removably attached to the distal hub 191 or other distal point of attachment on the occlusion device 10. Proximal retraction of the pullwire 240 while resisting proximal motion of the proximal hub 222 such as by using the distal end of the catheter 238 will cause enlargement of the occlusion device 10 as has been discussed.
- the pullwire 240 may then be locked with respect to the proximal hub 222 and severed or otherwise detached to enable removal of the deployment catheter 238 and proximal extension of the pullwire 240. Locking of the pullwire with respect to the proximal hub 222 may be accomplished in any of a variety of ways, such as by using interference fit or friction fit structures, adhesives, a knot or other technique depending upon the desired catheter design.
- the occlusion device 10 may be provided with a barrier 15 such as a mesh or fabric as has been previously discussed.
- Barrier 15 may be provided on only one hemisphere such as proximal face 216, or may be carried by the entire occlusion device 10 from proximal end 192 to distal end 190.
- the barrier may be secured to the radially inwardly facing surface of the supports 228, as illustrated in Figure 11 , or may be provided on the radially outwardly facing surfaces of supports 228, or both.
- FIG. 12 A further example of the occlusion device 10 is illustrated in Figure 12 , in which the apex 220 is elongated in an axial direction to provide additional contact area between the occlusion device 10 and the wall of the tubular structure.
- the apex 220 is elongated in an axial direction to provide additional contact area between the occlusion device 10 and the wall of the tubular structure.
- one or two or three or more anchors 195 may be provided on each support 228, depending upon the desired clinical performance.
- the occlusion device 10 illustrated in Figure 12 may also be provided with any of a variety of other features discussed herein, such as a partial or complete barrier 15.
- the occlusion device 10 illustrated in Figure 12 may be enlarged using any of the techniques disclosed elsewhere herein.
- An adjustable implant deployment system 300 comprises generally a catheter 302 for placing a detachable implant 304 within a body cavity or lumen, as has been discussed.
- the catheter 302 comprises an elongate flexible tubular body 306, extending between a proximal end 308 and a distal end 310.
- the catheter is shown in highly schematic form, for the purpose of illustrating the functional aspects thereof.
- the catheter body will have a sufficient length and diameter to permit percutaneous entry into the vascular system, and transluminal advancement through the vascular system to the desired deployment site.
- the catheter 302 will have a length within the range of from about 50 cm to about 150 cm, and a diameter of generally no more than about 15 French. Further dimensions and physical characteristics of catheters for navigation to particular sites within the body are well understood in the art and will not be further described herein.
- the tubular body 306 is further provided with a handle 309 generally on the proximal end 308 of the catheter 302.
- the handle 309 permits manipulation of the various aspects of the implant deployment system 300, as will be discussed below.
- Handle 309 may be manufactured in any of a variety of ways, typically by injection molding or otherwise forming a handpiece for single-hand operation, using materials and construction techniques well known in the medical device arts.
- the implant 304 may be in the form of any of those described previously herein, as modified below.
- the implant is movable from a reduced crossing profile to an enlarged crossing profile, such that it may be positioned within a body structure and advanced from its reduced to its enlarged crossing profile to obstruct bloodflow or perform other functions while anchored therein.
- the implant 304 may be biased in the direction of the enlarged crossing profile, may be neutrally biased or may be biased in the direction of the reduced crossing profile. Any modifications to the device and deployment system to accommodate these various aspects of the implant 304 may be readily accomplished by those of skill in the art in view of the disclosure herein.
- the distal end 314 of the implant 304 is provided with an implant plug 316.
- Implant plug 316 provides a stopping surface 317 for contacting an axially movable core 312.
- the core 312 extends axially throughout the length of the catheter body 302, and is attached at its proximal end to a core control 332 on the handle 309.
- the core 312 may comprise any of a variety of structures which has sufficient lateral flexibility to permit navigation of the vascular system, and sufficient axial column strength to enable reduction of the implant 304 to its reduced crossing profile. Any of a variety of structures such as hypotube, solid core wire, "bottomed out” coil spring structures, or combinations thereof may be used, depending upon the desired performance of the finished device.
- the core 312 comprises stainless steel tubing.
- the distal end of core 312 is positioned within a recess or lumen 322 defined by a proximally extending guide tube 320.
- the guide tube 320 is a section of tubing such as metal hypotube, which is attached at the distal end 314 of the implant and extends proximally within the implant 304.
- the guide tube 320 preferably extends a sufficient distance in the proximal direction to inhibit buckling or prolapse of the core 312 when distal pressure is applied to the core control 332 to reduce the profile of the implant 304.
- the guide tube 320 should not extend proximally a sufficient distance to interfere with the opening of the implant 304.
- the guide tube 320 may operate as a limit on distal axial advancement of the proximal end 324 of implant 304.
- the guide tube 320 preferably does not extend sufficiently far proximally from the distal end 314 to interfere with optimal opening of the implant 304.
- the specific dimensions are therefore relative, and will be optimized to suit a particular intended application.
- the implant 304 has an implanted outside diameter within the range of from about 5 mm to about 45 mm, and an axial implanted length within the range of from about 5 mm to about 45 mm.
- the guide tube 320 has an overall length of about 3 mm to about 35 mm, and an outside diameter of about 0.095 inches.
- FIG. 18 An alternate guide tube 320 is schematically illustrated in Figure 18 .
- the guide tube 320 comprises a plurality of tubular segments 321 spaced apart by an intervening space 323. This allows increased flexibility of the guide tube 320, which may be desirable during the implantation step, while retaining the ability of the guide tube 320 to maintain linearity of the core 312 while under axial pressure.
- three segments 321 are illustrated in Figure 18 , as many as 10 or 20 or more segments 321 may be desirable depending upon the desired flexibility of the resulting implant.
- each adjacent pair of segments 321 may be joined, by a hinge element 325 which permits lateral flexibility.
- the hinge element 325 comprises an axially extending strip or spine, which provides column strength along a first side of the guide tube 320.
- the guide tube 320 may therefore be curved by compressing a second side of the guide tube 320 which is generally offset from the spine 325 by about 180°.
- a limit on the amount of curvature may be set by adjusting the axial length of the space 323 between adjacent segments 321.
- each axial spine 325 may be rotationally offset from the next adjacent axial spine 325 to enable flexibility of the overall guide tube 320 throughout a 360° angular range of motion.
- each adjacent segment 321 may be provided by cutting a spiral groove or plurality of parallel grooves in a tubular element in between what will then become each adjacent pair of segments 321. In this manner, each tubular element 321 will be separated by an integral spring like structure, which can permit flexibility.
- the entire length of the guide tube 320 may comprise a spring.
- Each of the forgoing examples may be readily constructed by laser cutting or other cutting from a piece of tube stock, to produce a one piece guide tube 320.
- the guide tube 320 may be assembled from separate components and fabricated together using any of a variety of bonding techniques which are appropriate for the construction material selected for the tube 320.
- distal implant plug 316 extends within the implant 304 and is attached to the distal end of the guide tube 320.
- the implant plug 316 may be secured to the guide tube 320 and implant 304 in any of a variety of ways, depending upon the various construction materials. For example, any of a variety of metal bonding techniques such as a welding, brazing, interference fit such as threaded fit or snap fit, may be utilized. Alternatively, any of a variety of bonding techniques for dissimilar materials may be utilized, such as adhesives, and various molding techniques.
- the implant plug 316 comprises a molded polyethylene cap, and is held in place utilizing a distal cross pin 318 which extends through the implant 304, the guide tube 320 and the implant plug 316 to provide a secure fit against axial displacement.
- the proximal end 324 of the implant 304 is provided with a releasable lock 326 for attachment to a release element such as pull wire 328.
- Pull wire 328 extends proximally throughout the length of the tubular body 306 to a proximal pull wire control 330 on the handle 309.
- the term pull wire is intended to include any of a wide variety of structures which are capable of transmitting axial tension or compression such as a pushing or pulling force with or without rotation from the proximal end 308 to the distal end 310 of the catheter 302.
- monofilament or multifilament metal or polymeric rods or wires, woven or braided structures may be utilized.
- tubular elements such as a concentric tube positioned within the outer tubular body 306 may also be used as will be apparent to those of skill in the art.
- the pull wire 328 is releasably connected to the proximal end 324 of the implant 304. This permits proximal advancement of the proximal end of the implant 304, which cooperates with a distal retention force provided by the core 312 against the distal end of the implant to axially elongate the implant 304 thereby reducing it from its implanted configuration to its reduced profile for implantation.
- the proximal end of the pull wire 328 may be connected to any of a variety of pull wire controls 330, including rotational knobs, levers and slider switches, depending upon the design preference.
- the proximal end 324 of the implant 304 is thus preferably provided with a releasable lock 326 for attachment of the pullwire 328 to the deployment catheter.
- the releasable lock is formed by advancing the pullwire distally around a cross pin 329, and providing an eye or loop which extends around the core 312. As long as the core 312 is in position within the implant 304, proximal retraction of the pullwire 328 will advance the proximal end 324 of the implant 304 in a proximal direction. See Figure 17A .
- proximal retraction of the core 312 such as by manipulation of the core control 332 will pull the distal end of the core 312 through the loop on the distal end of the pullwire 328.
- the pullwire 328 may then be freely proximally removed from the implant 304, thereby enabling detachment of the implant 304 from the deployment system 300 within a treatment site. See Figure 17B .
- the implant deployment system 300 thus permits the implant 304 to be maintained in a low crossing profile configuration, to enable transluminal navigation to a deployment site. Following positioning at or about the desired deployment site, proximal retraction of the core 312 enables the implant 304 to radially enlarge under its own bias to fit the surrounding tissue structure. Alternatively, the implant can be enlarged under positive force, such as by inflation of a balloon or by a mechanical mechanism as is discussed elsewhere herein. Once the clinician is satisfied with the position of the implant 304, such as by injection of dye and visualization using conventional techniques, the core 312 is proximally retracted thereby releasing the lock 326 and enabling detachment of the implant 304 from the deployment system 300.
- the present invention permits the implant 304 to be enlarged or reduced by the clinician to permit repositioning and/or removal of the implant 304 as may be desired.
- the implant is radially enlarged or reduced by rotating a torque element extending throughout the deployment catheter.
- the elongate flexible tubular body 306 of the deployment catheter 302 includes a rotatable torque rod 340 extending axially therethrough.
- the proximal end of the torque rod 340 may be connected at a proximal manifold to a manual rotation device such as a hand crank, thumb wheel, rotatable knob or the like.
- the torque rod 340 may be connected to a power driven source of rotational energy such as a motor drive or air turbine.
- the distal end of the torque rod 340 is integral with or is connected to a rotatable core 342 which extends axially through the implant 304.
- a distal end 344 of the rotatable core 342 is positioned within a cavity 322 as has been discussed.
- torque rod or torque element are intended to include any of a wide variety of structures which are capable of transmitting a rotational torque throughout the length of a catheter body.
- solid core elements such as stainless steel, nitinol or other nickel titanium alloys, or polymeric materials may be utilized.
- the torque rod 340 is preferably provided with an axially extending central guidewire lumen. This may be accomplished by constructing the torque rod 340 from a section of hypodermic needle tubing, having an inside diameter of from about 0,0025 cm to 0,013 cm (0.001 inches to about 0.005 inches) or more greater than the outside diameter of the intended guidewire.
- Tubular torque rods 340 may also be fabricated or constructed utilizing any of a wide variety of polymeric constructions which include woven or braided reinforcing layers in the wall. Torque transmitting tubes and their methods of construction are well understood in the intracranial access and rotational atherectomy catheter arts, among others, and are not described in greater detail herein. Use of a tubular torque rod 340 also provides a convenient infusion lumen for injection of contrast media within the implant 304, such as through a port 343.
- the proximal end 324 of the implant 304 is provided with a threaded aperture 346 through which the core 342 is threadably engaged.
- rotation of the threaded core 342 in a first direction relative to the proximal end 324 of the implant 304 will cause the rotatable core 342 to advance distally. This distal advancement will result in an axial elongation and radial reduction of the implantable device 304.
- Rotation of the rotatable core 342 in a reverse direction will cause a proximal retraction of the rotatable core 342, thus enabling a radial enlargement and axial shortening of the implantable device 304.
- the deployment catheter 302 is further provided with an antirotation lock 348 between a distal end 350 of the tubular body 306 and the proximal end 324 of the implant 304.
- the rotational lock 348 may be conveniently provided by cooperation between a first surface 352 on the distal end 350 of the deployment catheter 302, which engages a second surface 354 on the proximal end 324 of the implantable device 304, to rotationally link the deployment catheter 302 and the implantable device 304.
- Any of a variety of complementary surface structures may be provided, such as an axial extension on one of the first and second surfaces for coupling with a corresponding recess on the other of the first and second surfaces.
- Such extensions and recesses may be positioned laterally offset from the axis of the catheter.
- they may be provided on the longitudinal axis with any of a variety of axially releasable anti-rotational couplings having at least one flat such as a hexagonal or other multifaceted cross sectional configuration.
- one or more projections 356 on the first surface 352 may engage a corresponding recess 358 on the second surface 354.
- Any of a variety of alternative complementary surface structures may also be provided, as will be apparent to those of skill in the art in view of the disclosure herein.
- the projection 356 is in the form of an axially extending pin for engaging a complimentary recess 358 on the proximal end 324 of the implant 304.
- Figure 19B illustrates an axially extending spline 356 for receipt within a complimentary axially extending recess 358.
- the various pin, spline and other structures may be reversed between the distal end of tubular body 306 and the proximal end 324 of the implant 304 as will be apparent to those of skill in the art in view of the disclosure herein.
- the torque rod 340 Upon placement of the implantable device 304 at the desired implantation site, the torque rod 340 is rotated in a direction that produces an axial proximal retraction. This allows radial enlargement of the radially outwardly biased implantable device 304 at the implantation site. Continued rotation of the torque rod 340 will cause the threaded core 342 to exit proximally through the threaded aperture 346. At that point, the deployment catheter 302 may be proximally retracted from the patient, leaving the implanted device 304 in place.
- the rotatable core 342 may be left within the implantable device 304, as may be desired depending upon the intended deployment mechanism.
- the distal end of the core 342 may be rotatably locked within the end cap 326, such as by including complimentary radially outwardly or inwardly extending flanges and grooves on the distal end of the core 342 and inside surface of the cavity 322.
- proximal retraction of the core 342 by rotation thereof relative to the implantable device 304 will pull the end cap 326 in a proximal direction under positive force. This may be desirable as a supplement to or instead of a radially enlarging bias built into the implantable device 304.
- a positive expansion force may also be achieved in the embodiment illustrated in FIG. 21 .
- a first coil 402 is fixedly attached to the proximal end 324 of the implant.
- a second coil 404 is rotatably locked within the end cap 326, such as by complimentary radially inwardly extending tabs or flanges 407 on the inside surface of the cavity 322, and radially inwardly extending groove or radially outwardly extending surface 408 on the outside surface of the distal end of the second coil.
- the second coil 404 can be rotatably locked within the end cap 326 by complimentary radially outwardly extending flanges on the outside surface of the distal end of the second coil, and grooves on the inside surface of the cavity.
- a torque rod 340 passes through an aperture 400 in the proximal end 324 of the implant 304, through the first coil 402, through the second coil 404, and into a fitting 412 in the distal end of the second coil.
- the distal end 414 of the torque rod 340 has an exterior cross-sectional profile that corresponds to the interior cross-sectional profile of the fitting 412. The torque rod is able to slide freely longitudinally within the fitting 412 and is able to apply a rotational torque to the fitting.
- the interior lumen of the fitting 412 may have an oval cross section.
- the exterior of the distal section of the distal end of the torque rod 414 preferably has a complimentary cross section.
- the complimentary cross sections could also be any other shape, such as a triangle, square, hexagon, ellipse, circle with one or more complimentary intruding and extruding pins, splines, flanges, grooves or other structures disclosed elsewhere herein, or any other regular or irregular polygon that would allow the torque rod 340 to apply a rotational torque to the fitting 412.
- applying a rotational force to the torque rod causes the second coil 404 to engage the first coil 402. This engagement allows rotation of the torque rod in a first direction to cause axial compression and radial expansion of the implant 304. This allows for precise fitting of the implant within the cavity.
- the first coil 402 and the second coil 404, together with the adjacent tubular support may be manufactured in any of a variety of ways which will be understood by those of skill in the art.
- a stainless steel tube stock having an inside diameter of about 0,10 cm (0.040 inches) and an outside diameter of about 0,16 cm (0.065) inches is laser-cut according to conventional techniques to form the spiral ribbon.
- the width of the ribbon in the axial direction is about 0,035 cm (0.014 inches), and the spacing between adjacent windings of the ribbon, measured in the axial direction, is about 0,05 cm (0.020 inches).
- the dimensions may be varied widely, depending upon the intended clinical application, construction materials, desired flexibility, and other choices which can be optimized by those of skill in the art in view of the disclosure herein.
- first coil 402 and second coil 404 have an X approximately equivalent diameter and complimentary structure to allow threadable engagement as illustrated, for example, in Figure 22A .
- one of the first coil 402 or second coil 404 may be replaced by a tubular or other element which is dimensioned to reside adjacent the radially inwardly facing surface of the complimentary coil 402 or 404 or the radially outwardly facing surface of the coil 402 or 404.
- the resulting component may be a tubular element, or axially extending element, having a flange or post which extends radially outwardly or radially inwardly through the space between adjacent windings on the corresponding coil.
- a tubular body may replace the first coil 402 and have an outside diameter of slightly less than the inside diameter of the second coil 404.
- the tubular body is provided with one or more radially outwardly extending post or flanges, to engage the spiral groove in the second coil 404. Operation of the device is similar to that described previously, such that rotation of one component with respect to the other will cause an axial compression or expansion across the operating range.
- the first coil 402 is rotatably locked within the proximal end 324 of the implant, and the second coil 404, is fixedly attached to the end cap 326.
- the torque rod 340 passes through an aperture 400 in the proximal end 324 of the implant 304, and into a fitting 412 in the proximal end of the first coil 402.
- the first coil 402 is rotatably locked within the proximal end 324 of the implant by any conventional means known to those of ordinary skill in the art, such as by inwardly extending radial flanges 407 and complimentary grooves 408 on the outer surface of the coil.
- the distal end 414 of the torque rod 340 has an exterior cross-sectional profile that corresponds to the interior cross-sectional profile of the fitting 412, as described above in the previous embodiment.
- applying a rotational force to the torque rod causes the first coil 402 to engage the second coil 404. This engagement causes axial compression and radial expansion of the implant 304. This allows for precise fitting of the implant within the cavity as described above.
- first and second coils may be any type of threadably engageable first and second members as are conventionally used in the art. The optimum type of threadable engagement can be determined for any particular application and for any particular material or combination of materials through routine experimentation by one or ordinary skill in the art based on the disclosures herein.
- the example of Figure 19 can be modified to provide expansion under positive force by providing a rotatable engagement between the distal end 344 of rotatable core 342 and the surface of cavity 322. This will allow rotation of the core 342 to either radially expand or contract the implant.
- Rotatable screw mechanisms may, however, reduce the flexibility of the device compared to the examples of Figures 21-24 , which may inhibit transluminal navigation.
- the distal end of the implant may be connected to a pull string or pull wire, which extends proximally throughout the length of the catheter. Proximal retraction on the pull wire will axially proximally advance the distal end of the implant, thereby providing positive radial expansion force.
- a pull string or pull wire which extends proximally throughout the length of the catheter.
- Proximal retraction on the pull wire will axially proximally advance the distal end of the implant, thereby providing positive radial expansion force.
- Any of a variety of releasable ratchet or other engagement structures may be provided within the implant, for retaining the implant in the expanded configuration.
- the pull wire may be released, and proximally retracted from the catheter in a manner similar to that discussed in connection with the embodiment of Figure 17 .
- the pull wire simply loops around a post or through an eye connected mechanically to the distal end of the implant. Both ends of the pull wire extend all the way to the proximal end of the device. One end of the pull wire may be released from its attachment to the proximal end of the device, and the second end of the pull wire may be proximally retracted, to remove the wire from the device following active expansion at the treatment site.
- the above described axial expansion may be optionally combined with an implant that is positively, negatively or neutrally biased toward expansion.
- the optimum combination of passive and active expansion can be determined for any particular application and for any particular material or combination of materials through routine experimentation by one or ordinary skill in the art based on the disclosures herein.
- one or more tissue engagement anchors may be provided, as has been discussed, for example, in connection with anchors 195 in the embodiments of Figures 9 - 12 .
- One or more anchors may also or alternatively be provided, extending distally along or substantially parallel to the longitudinal axis of the device.
- the longitudinally disposed anchors do not extend beyond the distal end 190 of the occlusion device during transluminal navigation to the deployment site.
- one or more distal anchors are extended beyond the distal end 190 of the occlusion device in order to secure the occlusion device to the surrounding tissue.
- the distal anchor or anchors may be extended beyond the distal tip 190 before or during deployment. Extending the distal anchor or anchors before or during deployment may assist in deploying or positioning the device.
- the anchors may have sharpened distal tips to facilitate penetration into the surrounding tissue.
- the anchor 420 has a distal tissue engaging section 422.
- the distal section 422 is laser-cut from tube stock to form a helix with a circular cross section (corkscrew) with a sharpened distal tip 424.
- the helical distal section 422 is threadably engaged with the distal end 190 of the occlusion device via an engaging member 430 such as a complementary thread or projection.
- a bridge 432 may be provided between at least two of the coils of the distal section 422. The bridge 432 places a rotational limit on the extent to which the anchor can advance toward the proximal end of the occlusion device.
- the bridge 432 is between the second and third helical coils from the sharpened distal tip 424. In other embodiments, the bridge 432 will connect other helical coils depending on the specific application. Alternative limiting structures may also be used, to limit the proximal and/or distal axial travel of the tissue engaging section 422 with respect to the distal end 190 of the occlusion device.
- the proximal section 426 of the anchor 420 has a central lumen or cavity 428. As illustrated in Fig. 25A the cavity 428 preferably has a non-round cross section.
- a torque rod 340 has a distal end 414. As illustrated in Fig. 25B , the exterior of the distal end of the torque rod 414 preferably has a complimentary cross section to the interior cross section of the cavity 428.
- the complimentary cross sections can be other shapes, such as a triangle, square, hexagon, ellipse, circle with one or more complimentary intruding and extruding pins, splines, flanges, grooves or other structures disclosed elsewhere herein, or any other regular or irregular polygon that allows the torque rod 340 to apply a rotational torque to the anchor 420.
- applying a rotational force to the torque rod 340 causes the helical distal section 422 to threadably engage the engaging member 430.
- the sharpened tip 424 facilitates the penetration of the helical distal section 422 into the body tissue 434.
- the torque rod 340 may be retracted proximally and removed from the device.
- the anchor 420 and the torque rod 340 both contain a lumen that allows for the introduction of visualizable media on either side of the occlusion device (not illustrated).
- the torque rod 340 can be reinserted distally into the anchor and the opposite rotational torque applied to disengage the coils from the tissue.
- the anchor 420 is a biocompatible wire or ribbon, preferably made of stainless steel, nitinol or elgiloy.
- the distal section 440 of the anchor is biased to form a curve or hook and the distal tip 442 is sharpened to facilitate tissue penetration.
- the distal section 440 of the anchor is biased to form at least about a 60 degree and as much as about a 300 degree curve or more.
- the distal section 440 is biased to form a curve of about 180 degrees.
- the anchor 420 resides in a substantially linear position within a lumen 444 in an active anchoring device and does not extend beyond the distal tip 191 of the occlusion device.
- the lumen 444 is disposed substantially along the longitudinal axis of the occlusion device and may be disposed concentrically, next to, or substantially parallel to any other longitudinally disposed structures, such as the torque rod or collapsing shaft disclosed herein.
- the anchor 420 is advanced distally through lumen 444, and through a lumen 446 in the distal tip 190 of the occlusion device.
- the anchor 420 may be advanced by any of the conventional means known to those of ordinary skill in the art to maneuver an object at the distal end of a catheter, such as those described elsewhere herein.
- the proximal section of the anchor 420 is releasably in contact with and/or attached to the distal end of a deployment shaft 456.
- the proximal end of the deployment shaft has an appropriate control, such as a button, knob, lever or handle.
- the anchor 420 may also be advanced by a biasing structure such as a spring or coil.
- the sharp distal end 442 of the anchor engages the tissue.
- the bias of the distal section of the anchor causes the sharp distal tip 442 to travel along an arcuate pathway through the tissue and optionally toward an anchor capture structure 448.
- the anchor capture structure 448 may be a second lumen or recess in the distal tip of the occlusion device.
- the distal section 420 of the anchor thereby forms a loop, or hook, through the tissue.
- the anchor capture structure 448 need not be a second lumen, but can be any structure capable of securing the distal tip 442 of the anchor. In particular embodiments, depending on the desired application, selected material, and shape of the anchor 420, the anchor capture structure 448 may be unnecessary. The optimal anchor configuration, if any, can be determined based on routine experimentation by one of ordinary skill in the art based on the disclosures herein. After the anchor is positioned in the tissue, the deployment shaft 456 is detached from the anchor 420 at release point 457.
- the anchor 420 is a coil or spring of wire or ribbon, preferably made of stainless steel, nitinol or elgiloy.
- the anchor 420 may reside within either an axially movable support tube 450 or within a lumen extending through the distal tip 191.
- the support tube 450 or the lumen extends along the longitudinal axis of the occlusion device and may be disposed concentrically, next to, or substantially parallel to any other longitudinally disposed structures, such as the torque rod or collapsing shaft disclosed herein.
- the distal tip 452 of the support tube 450 is sharpened to facilitate tissue penetration.
- the support tube comprises a hypodermic needle tube having an OD of about 0,14 cm (0.056 inches) and an ID of about 0,12 cm (0.050 inches).
- the support tube 450 is advanced distally through a lumen 454 in the distal dip 191 of the occlusion device.
- the support tube 450 may be advanced by any of the conventional means known to those of ordinary skill in the art to maneuver an object at the distal end of a catheter, such as an axially movable push wire, or by extending the hypotube proximally throughout the length of the catheter body to a proximal slider switch or other control.
- the support tube 450 may be a distal section of an axially movable deployment shaft 456.
- the proximal end of the deployment shaft has an appropriate control such as a knob, lever or handle.
- the support tube 450 may also be advanced by a biasing structure such as a spring or coil.
- Advancing the deployment shaft 456 distally advances the support tube 450 beyond the distal tip of the occlusion device.
- the sharp distal tip 452 is advanced until it penetrates the tissue.
- the anchor 420 may be held axially stationary with respect to the tissue and the support tube 450 may be proximally withdrawn until the anchor 420 engages the tissue. Moving or restraining the anchor 420 with respect to the support tube 450 may be accomplished by a control wire 460 disposed within the lumen of the deployment shaft.
- the distal end of the control wire 460 may be releasably connected to the anchor 420, or simply abut the proximal end of the anchor, while the proximal end of the control wire has appropriate control means as disclosed elsewhere herein.
- the anchor may also be rotated into the distal tissue, particularly in an example which omits a separate support tube 450.
- the support tube 450 is withdrawn from the occlusion device.
- the proximal portion of the anchor 420 engages a locking pin or flange 458 in the lumen 454 to assist in securing the occlusion device to the tissue.
- the distal end of the tubular body 306 may be provided with a zone or point of enhanced lateral flexibility. This may be desirable in order allow the implant to seat in the optimal orientation within the left atrial appendage, and not be restrained by a lack of flexibility in the tubular body 306. This may be accomplished in any of a variety of ways, such as providing the distal most one or two or three centimeters or more of the tubular body 306 with a spring coil configuration. In this manner, the distal end of the tubular body 306 will be sufficiently flexible to allow the implant 304 to properly seat within the LAA.
- This distal flex zone on the tubular body 306 may be provided in any of a variety of ways, such as by cutting a spiral slot in the distal end of the tubular body 306 using laser cutting or other cutting techniques.
- the components within the tubular body 306 such as torque rod 340 may similarly be provided with a zone of enhanced flexibility in the distal region of the tubular body 306.
- the implantable device 304 may also be retrieved and removed from the body in accordance with a further aspect of the present invention.
- a previously implanted device 304 is illustrated as releasably coupled to the distal end of the tubular body 306, as has been previously discussed. Coupling may be accomplished by aligning the tubular body 306 with the proximal end 324 of the deployed implant 304, under fluoroscopic visualization, and distally advancing a rotatable core 342 through the threaded aperture 346. Threadable engagement between the rotatable core 342 and aperture 346 may thereafter be achieved, and distal advancement of core 342 will axially elongate and radially reduce the implant 304.
- the tubular body 306 is axially moveably positioned within an outer tubular delivery or retrieval catheter 360.
- Catheter 360 extends from a proximal end (not illustrated) to a distal end 362.
- the distal end 362 is preferably provided with a flared opening, such as by constructing a plurality of petals 364 for facilitating proximal retraction of the implant 304 as will become apparent.
- Petals 364 may be constructed in a variety of ways, such as by providing axially extending slits in the distal end 362 of the delivery catheter 360. In this manner, preferably at least about three, and generally at least about four or five or six petals or more will be provided on the distal end 362 of the delivery catheter 360. Petals 364 manufactured in this manner would reside in a first plane, transverse to the longitudinal axis of the delivery catheter 360, if each of such petals 364 were inclined at 90 degrees to the longitudinal axis of the delivery catheter 360.
- a second layer of petals 365 are provided, which would lie in a second, adjacent plane if the petals 365 were inclined at 90 degrees to the longitudinal axis of the delivery catheter 360.
- the second plane of petals 365 is rotationally offset from the first plane of petals 364, such that the second petals 365 cover the spaces 367 formed between each adjacent pair of petals 365.
- the use of two or more layers of staggered petals 364 and 365 has been found to be useful in retrieving implants 304, particularly when the implant 304 carries a plurality of tissue anchors 195.
- the petals 364 and 365 may be manufactured from any of a variety of polymer materials useful in constructing medical device components such as the delivery catheter 360. This includes, for example, polyethylene, PET, PEEK, PEBAX, and others well known in the art.
- the second petals 365 may be constructed in any of a variety of ways. In one convenient construction, a section of tubing which concentrically fits over the delivery catheter 360 is provided with a plurality of axially extending slots in the same manner as discussed above. The tubing with a slotted distal end may be concentrically positioned on the catheter 360, and rotated such that the space between adjacent petals 365 is offset from the space between adjacent petals 364. The hub of the petals 365 may thereafter be bonded to the catheter 360, such as by heat shrinking, adhesives, or other bonding techniques known in the art.
- the radially reduced implant 304 is proximally retracted part way into the delivery catheter 360. This can be accomplished by proximally retracting the tubular body 306 and/or distally advancing the catheter 360. As illustrated in Figure 20b , the tubular body 306 having the implant 304 attached thereto is proximally retracted a sufficient distance to position the tissue anchors 195 within the petals 364. The entire assembly of the tubular body 306, within the delivery catheter 360 may then be proximally retracted within the transeptal sheath 366 or other tubular body as illustrated in Figure 20c .
- the collapsed petals 364 allow this to occur while preventing engagement of the tissue anchors 195 with the distal end of the transeptal sheath 366 or body tissue.
- the entire assembly having the implantable device 304 contained therein may thereafter be proximally withdrawn from or repositioned within the patient.
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Abstract
Description
- Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability. There are over 700,000 strokes per year in the United States alone. Of these, roughly 100,000 are hemoragic, and 600,000 are ischemic (either due to vessel narrowing or to embolism). The most common cause of embolic stroke emanating from the heart is thrombus formation due to atrial fibrillation. Approximately 80,000 strokes per year are attributable to atrial fibrillation. Atrial fibrillation is an arrhythmia of the heart that results in a rapid and chaotic heartbeat that produces lower cardiac output and irregular and turbulent blood flow in the vascular system. There are over five million people worldwide with atrial fibrillation, with about four hundred thousand new cases reported each year. Atrial fibrillation is associated with a 500 percent greater risk of stroke due to the condition. A patient with atrial fibrillation typically has a significantly decreased quality of life due, in part, to the fear of a stroke, and the pharmaceutical regimen necessary to reduce that risk.
- For patients who develop atrial thrombus from atrial fibrillation, the clot normally occurs in the left atrial appendage (LAA) of the heart. The LAA is a cavity which looks like a small finger or windsock and which is connected to the lateral wall of the left atrium between the mitral valve and the root of the left pulmonary vein. The LAA normally contracts with the rest of the left atrium during a normal heart cycle, thus keeping blood from becoming stagnant therein, but often fails to contract with any vigor in patients experiencing atrial fibrillation due to the discoordinate electrical signals associated with AF. As a result, thrombus formation is predisposed to form in the stagnant blood within the LAA.
- Blackshear and Odell have reported that of the 1288 patients with non-rheumatic atrial fibrillation involved in their study, 221 (17%) had thrombus detected in the left atrium of the heart. Blackshear JL, Odell JA., Appendage Obliteration to Reduce Stroke in Cardiac Surgical Patients With Atrial Fibrillation. Ann Thorac. Surg., 1996.61(2):755-9. Of the patients with atrial thrombus, 201 (91%) had the atrial thrombus located within the left atrial appendage. The foregoing suggests that the elimination or containment of thrombus formed within the LAA of patients with atrial fibrillation would significantly reduce the incidence of stroke in those patients.
- Pharmacological therapies for stroke prevention such as oral or systemic administration of warfarin or the like have been inadequate due to serious side effects of the medications and lack of patient compliance in taking the medication. Invasive surgical or thorascopic techniques have been used to obliterate the LAA, however, many patients are not suitable candidates for such surgical procedures due to a compromised condition or having previously undergone cardiac surgery. In addition, the perceived risks of even a thorascopic surgical procedure often outweigh the potential benefits. See Blackshear and Odell, above. See also Lindsay BD., Obliteration of the Left Atrial Appendage: A Concept Worth Testing, Ann Thorac. Surg., 1996.61 (2):515.
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US 6,290,674 discloses a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. It is also disclosed that the distal end of the closure catheter may be provided with one or more anchor supports for removably carrying one or more tissue anchors. -
US 6,371,971 discloses a filter system for temporary placement of a filter in an artery or vein is disclosed. The filter system includes a guidewire that is first positioned across a lesion within a vessel. The guidewire may include a distal stop. A slideable filter is then advanced along the guidewire using an advancing mechanism, typically an elongate member slideable over the guidewire and contacting the filter. A capture sheath may be disposed about the filter during advancement. Once the filter is positioned downstream of the lesion, the capture sheath is withdrawn, allowing the filter to expand. Further distal advancement of the filter is prohibited by the stop. After expansion of the filter, the capture sheath and the advancing mechanism are withdrawn from the region of interest, and removed from the patient's vessel. The filter may then be retrieved using a capture sheath or exchanged for a second filter after removing the first filter. - Despite the various efforts in the prior art, there remains a need for a minimally invasive method and associated devices for reducing the risk of thrombus formation in the left atrial appendage.
- There is provided in accordance with the present invention an adjustable occlusion device deployment system, as set forth in the accompanying claims.
- Further features and advantages of the present invention will become apparent to those of ordinary skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.
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FIG. 1 is a perspective view of an occlusion device. -
FIG. 2 is a side elevational view of the occlusion device shown inFIG. 1 . -
FIG. 3 is a perspective view of an alternate example. -
FIG. 4 is a side elevational view of the example shown inFIG. 3 . -
FIG. 5 is a perspective view of a further example. -
FIG. 6 is a side elevational view of the example ofFIG. 5 . -
FIG. 7 is a perspective view of a support structure for a further occlusion device. -
FIG. 7A is a side elevational view of the device ofFIG. 7 . -
FIG. 7B is an end view taken along the line 7B-7B ofFIG. 7A . -
FIG. 8 is a schematic illustration of an inflatable balloon positioned within the occlusion device ofFIG. 7 . -
FIG. 9 is a schematic view of a pull string deployment embodiment of the occlusion device ofFIG. 7 . -
FIGS. 10 and 11 are side elevational schematic representations of partial and complete barrier layers on the occlusion device ofFIG. 7 . -
FIG. 12 is a side elevational schematic view of an alternate occlusion device. -
FIG. 13 is a schematic view of a bonding layer mesh for use in forming a composite barrier membrane. -
FIG. 14 is an exploded cross sectional view of the components of a composite barrier member. -
FIG. 15 is a cross sectional view through a composite barrier formed from the components illustrated inFIG. 14 . -
FIG. 16 is a top plan view of the composite barrier illustrated inFIG. 15 . -
FIG. 17 is a schematic view of a deployment system. -
FIG. 17A is an enlarged view of a releasable lock in an engaged configuration. -
FIG. 17B is an enlarged view as inFIG. 17A , with the core axially retracted to release the implant. -
FIG. 18 is a perspective view of a flexible guide tube for use in the configurations ofFIG. 17 and/orFIG. 19 . -
FIG. 19 is a schematic view of an alternate deployment system. -
FIGs. 19A - 19B illustrate a removal sequence for an implanted device. -
FIG. 20 is a schematic cross sectional view through the distal end of a retrieval catheter having an occlusion device removably connected thereto. -
FIG. 20A is a side elevational schematic view of the system illustrated inFIG. 20 , with the occlusion device axially elongated and radially reduced. -
FIG. 20B is a side elevational schematic view as inFIG. 20A , with the occlusion device drawn part way into the delivery catheter. -
FIG. 20C is a schematic view as inFIG. 20B , with the occlusion device and delivery catheter drawn into a transeptal sheath. -
FIG. 21 is a side view of an active expander in accordance with the present invention in the radially compressed state. -
FIG. 21A is an exploded view of the distal end of the active expander inFIG. 21 . -
FIGs. 21B. and 21C are cross-sectional views of the torque rod and fitting inFIGs. 21 and21A . -
FIG. 22A is a side view of the active expander inFIG. 21 in a partially radially expanded state. -
FIG. 22B is a side view of the active expander inFIG. 21 in a radially expanded state. -
FIG. 23 is a side view of another embodiment of an active expander in the radially compressed state. -
FIG. 24A is a side view of the active expander inFIG. 23 in a partially radially expanded state. -
FIG. 24B is a side view of the active expander inFIG. 23 in a radially expanded state. -
FIGs. 24C and 24D are cross-sectional views of the torque rod and fitting inFIGs. 23 ,24A and24B . -
FIG. 25 is a side view of an active anchor in accordance with the present invention in an undeployed state. -
FIG. 25A and 25B are cross-sectional views of the torque rod and cavity inFIG. 25 . -
FIG. 26 is a side view of the active anchor ofFig. 25 in a deployed state. -
FIG. 27A is a side fragmentary view an active anchor in an undeployed state. -
FIG. 27B is a side view of the active anchor inFIG. 27A , in a partially deployed state. -
FIG. 27C is a side view of the active anchor inFIG. 27A in a deployed state. -
FIG. 28A is a side fragmentary view of an active anchor in an undeployed state. -
FIG. 28B is a side view of the active anchor in FIB. 28A, in a partially deployed state. -
FIG. 28C is a side view of the active anchor inFIG. 28A , in a deployed state. - Only
figures 25 and26 disclose embodiments of the invention. - Referring to
FIGS. 1 and 2 , there is illustrated oneocclusion device 10. - The
occlusion device 10 comprises an occludingmember 11 comprising aframe 14 and abarrier 15. In the illustrated example, theframe 14 comprises a plurality of radially outwardly extendingspokes 17 each having a length within the range of from about 0.5 cm to about 2 cm from ahub 16. In one embodiment, the spokes have an axial length of about 1.5 cm. Depending upon the desired introduction crossing profile of thecollapsed occlusion device 10, as well as structural strength requirements in the deployed device, anywhere within the range of from about 3 spokes to about 40 spokes may be utilized. In some embodiments, anywhere from about 12 to about 24 spokes are utilized, and, 18 spokes are utilized in one example. - The spokes are advanceable from a generally axially extending orientation such as to fit within a tubular introduction catheter to a radially inclined orientation as illustrated in
FIG. 1 and FIG. 2 following deployment from the catheter. In a self-expandable example, the spokes are biased radially outwardly such that the occlusion member expands to its enlarged, implantation cross-section under its own bias following deployment from the catheter. Alternatively, the occlusion member may be enlarged using any of a variety of enlargement structures such as an inflatable balloon, or a catheter for axially shortening the occlusion member, as is discussed further below. - Preferably, the spokes comprise a metal such as stainless steel, Nitinol, Elgiloy, or others which can be determined through routine experimentation by those of skill in the art. Wires having a circular or rectangular cross-section may be utilized depending upon the manufacturing technique. In one example, rectangular cross section spokes are cut such as by known laser cutting techniques from tube stock, a portion of which forms the
hub 16. - The
barrier 15 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials forbarrier 15 can be determined through routine experimentation by those of skill in the art. Thebarrier 15 may be provided on either one or both axially facing sides of the occlusion member. In one example, thebarrier 15 comprises two layers, with one layer on each side of theframe 14. The two layers may be bonded to each other around thespokes 17 in any of a variety of ways, such as by heat bonding with or without an intermediate bonding layer such as polyethylene or FEP, adhesives, sutures, and other techniques which will be apparent to those of skill in the art in view of the disclosure herein. Thebarrier 15 preferably has a thickness of no more than about 0.003" and a porosity within the range of from about 5µm to about 60µm. - The
barrier 15 in one example preferably is securely attached to theframe 14 and retains a sufficient porosity to facilitate cellular ingrowth and/or attachment. One method of manufacturing a suitablecomposite membrane barrier 15 is illustrated inFigures 13-16 . As illustrated schematically inFigure 13 , abonding layer 254 preferably comprises a mesh or other porous structure having an open surface area within the range of from about 10% to about 90%. Preferably, the open surface area of the mesh is within the range of from about 30% to about 60%. The opening or pore size of thebonding layer 254 is preferably within the range of from about 0,013 cm (0.005 inches) to about 0,13 cm (0.050 inches) and, in one embodiment, is about 0,05 cm (0.020 inches). The thickness of thebonding layer 254 can be varied widely, and is generally within the range of from about 0,0013 cm (0.0005 inches) to about 0,013 cm (0.005 inches). In an example, thebonding layer 254 has a thickness of about 0,0025 cm to 0,0050 cm (0.001 to about 0.002 inches). One suitable polyethylene bonding mesh is available from Smith and Nephew, under the code SN9. - Referring to
Figure 14 , thebonding layer 254 is preferably placed adjacent one or both sides of a spoke orother frame element 14. Thebonding layer 254 and frame 14 layers are then positioned in-between afirst membrane 250 and asecond membrane 252 to provide a composite membrane stack. Thefirst membrane 250 andsecond membrane 252 may comprise any of a variety of materials and thicknesses, depending upon the desired functional result. Generally, the membrane has a thickness within the range of from about 0,0013 cm to 0,0254 cm (0.0005 inches to about 0.010 inches). In one embodiment, themembranes - The composite stack is heated to a temperature of from about 200° F to about 300° F, for about 1 minute to about 5 minutes under pressure to provide a finished composite membrane assembly with an embedded
frame 14 as illustrated schematically inFigure 15 . The final composite membrane has a thickness within the range of from about 0,0025 to 0,025 cm (0.001 inches to about 0.010 inches), and, preferably, is about 0,0050 to 0,008 cm (0.002 to about 0.003 inches) in thickness. However, the thicknesses and process parameters of the foregoing may be varied considerably, depending upon the materials of thebonding layer 254 thefirst layer 250 and thesecond layer 252. - As illustrated in top plan view in
Figure 16 , the resulting finished composite membrane has a plurality of "unbonded" windows orareas 256 suitable for cellular attachment and/or ingrowth. Theattachment areas 256 are bounded by theframe 14 struts, and the cross-hatch or other wall pattern formed by thebonding layer 254. Preferably, aregular window 256 pattern is produced in thebonding layer 254. - The foregoing procedure allows the bonding mesh to flow into the first and
second membranes composite membrane 15 greater strength (both tensile and tear strength) than the components without the bonding mesh. The composite allows uniform bonding while maintaining porosity of themembrane 15, to facilitate tissue attachment. By flowing the thermoplastic bonding layer into the pores of the outer mesh layers 250 and 252, the composite flexibility is preserved and the overall composite layer thickness can be minimized. - Referring back to
Figures 1 and 2 , theocclusion device 10 may be further provided with a bulking element orstabilizer 194. Thestabilizer 194 may be spaced apart along an axis from the occludingmember 11. In the illustrated embodiment, adistal end 190 and aproximal end 192 are identified for reference. The designation proximal or distal is not intended to indicate any particular anatomical orientation or deployment orientation within the deployment catheter. As shown inFIGS. 1 and 2 , thestabilizer 194 is spaced distally apart from the occludingmember 11. - For use in the LAA, the occluding
member 11 has an expanded diameter within the range of from about 1 cm to about 5 cm, and, in one embodiment, about 3 cm. The axial length of the occludingmember 11 in an expanded, unstressed orientation from thedistal end 192 to thehub 16 is on the order of about 1 cm. The overall length of theocclusion device 10 from thedistal end 192 to theproximal end 190 is within the range of from about 1.5 cm to about 4 cm and, in one example, about 2.5 cm. The axial length of thestabilizer 194 betweendistal hub 191 andproximal hub 16 is within the range of from about 0.5 cm to about 2 cm, and, in one embodiment, about 1 cm. The expanded diameter of thestabilizer 194 is within the range of from about 0.5 cm to about 2.5 cm, and, in one example, about 1.4 cm. The outside diameter of thedistal hub 191 andproximal hub A 16 is about 2.5 mm. - Preferably, the
occlusion device 10 is provided with one or more retention structures for retaining the device in the left atrial appendage or other body cavity or lumen. In the illustrated example, a plurality of barbs orother anchors 195 are provided, for engaging adjacent tissue to retain theocclusion device 10 in its implanted position and to limit relative movement between the tissue and the occlusion device. The illustrated anchors are provided on one or more of thespokes 17, or other portion offrame 14. Preferably, every spoke, every second spoke or every third spoke are provided with one or two or more anchors each. - The illustrated anchor is in the form of a barb, with one on each spoke for extending into tissue at or near the opening of the LAA. Depending upon the example, two or three barbs may alternatively be desired on each spoke. In the single barb embodiment of
FIG. 7 , each barb is inclined in a proximal direction. This is to inhibit proximal migration of the implant out of the left atrial appendage. In this context, distal refers to the direction into the left atrial appendage, and proximal refers to the direction from the left atrial appendage into the heart. - Alternatively, one or more barbs may face distally, to inhibit distal migration of the occlusion device deeper into the LAA. Thus the implant may be provided with at least one proximally facing barb and at least one distally facing barb. For example, in an example of the type illustrated in
Figure 12 , discussed below, a proximal plurality of barbs may be inclined in a first direction, and a distal plurality of barbs may be inclined in a second direction, to anchor the implant against both proximal and distal migration. - One or
more anchors 195 may also be provided on thestabilizer 194, such that it assists not only in orienting theocclusion device 10 and resisting compression of the LAA, but also in retaining theocclusion device 10 within the LAA. Any of a wide variety of structures may be utilized foranchor 195, either on the occludingmember 11 or thestabilizer 194 or both, such as hooks, barbs, pins, sutures, adhesives, ingrowth surfaces and others which will be apparent to those of skill in the art in view of the disclosure herein. - In use, the
occlusion device 10 is preferably positioned within a tubular anatomical structure to be occluded such as the left atrial appendage. In a left atrial appendage application, the occludingmember 11 is positioned across or near the opening to the LAA and thestabilizer 194 is positioned within the LAA. Thestabilizer 194 assists in the proper location and orientation of the occludingmember 11, as well as resists compression of the LAA behind the occludingmember 11. The present inventors have determined that following deployment of an occludingmember 11 without astabilizer 194 or other bulking structure to resist compression of the LAA, normal operation of the heart may cause compression and resulting volume changes in the LAA, thereby forcing fluid past the occludingmember 11 and inhibiting or preventing a complete seal. Provision of astabilizer 194 dimensioned to prevent the collapse or pumping of the LAA thus minimizes leakage, and provision of the barbs facilitates endothelialization or other cell growth across the occludingmember 11. - The
stabilizer 194 is preferably movable between a reduced cross-sectional profile for transluminal advancement into the left atrial appendage, and an enlarged cross-sectional orientation as illustrated to fill or to substantially fill a cross-section through the LAA. The stabilizing member may enlarge to a greater cross section than the (pre-stretched) anatomical cavity, to ensure a tight fit and minimize the likelihood of compression. One convenient construction includes a plurality ofelements 196 which are radially outwardly expandable in response to axial compression of adistal hub 191 towards aproximal hub 16.Elements 196 each comprise adistal segment 198 and aproximal segment 202 connected by abend 200. Theelements 196 may be provided with a bias in the direction of the radially enlarged orientation as illustrated inFIG. 2 , or may be radially expanded by applying an expansion force such as an axially compressive force betweendistal hub 191 andproximal hub 16 or a radial expansion force such as might be applied by an inflatable balloon.Elements 196 may conveniently be formed by laser cutting the same tube stock as utilized to construct thedistal hub 191,proximal hub 16 andframe 14, as will be apparent to those of skill in the art in view of the disclosure herein. Alternatively, the various components of theocclusion device 10 may be separately fabricated or fabricated in subassemblies and secured together during manufacturing. - As a post implantation step for any of the occlusion devices disclosed herein, a radiopaque dye or other visualizable media may be introduced on one side or the other of the occlusion device, to permit visualization of any escaped blood or other fluid past the occlusion device. For example, in the context of a left atrial appendage application, the occlusion device may be provided with a central lumen or other capillary tube or aperture which permits introduction of a visualizable dye from the deployment catheter through the occlusion device and into the entrapped space on the distal side of the occlusion device. Alternatively, dye may be introduced into the entrapped space distal to the occlusion device such as by advancing a small gauge needle from the deployment catheter through the
barrier 15 on the occlusion device, to introduce dye. - Modifications to the
occlusion device 10 are illustrated inFigures 3-4 . Theocclusion device 10 comprises anocclusion member 11 and a stabilizingmember 194 as previously discussed. In the present example, however, each of thedistal segments 198 inclines radially outwardly in the proximal direction and terminates in aproximal end 204. Theproximal end 204 may be provided with an atraumatic configuration, for pressing against, but not penetrating, the wall of the left atrial appendage or other tubular body structure. Three or moredistal segments 198 are preferably provided, and generally anywhere within the range of from about 6 to about 20distal segments 198 may be used. In one example, 9distal segments 198 are provided. In tins example, three of thedistal segments 198 have an axial length of about 5 mm, and 6 of thedistal segments 198 have an axial length of about 1 cm. Staggering the lengths of thedistal segments 198 may axially elongate the zone in the left atrial appendage against which the proximal ends 204 provide anchoring support for the occlusion device. - The
occlusion device 10 illustrated inFigures 3 and 4 is additionally provided with ahinge 206 to allow the longitudinal axis of theocclusion member 11 to be angularly oriented with respect to the longitudinal axis of the stabilizingmember 194. In the illustrated example, thehinge 206 is a helical coil, although any of a variety of hinge structures can be utilized. The illustrated example may be conveniently formed by laser cutting a helical slot through a section of the tube from which the principal structural components of theocclusion device 10 are formed. At the distal end of thehinge 206, anannular band 208 connects thehinge 206 to a plurality of axially extendingstruts 210. In the illustrated embodiment, threeaxial struts 210 are provided, spaced equilaterally around the circumference of the body. Axial struts 210 may be formed from a portion of the wall of the original tube stock, which portion is left in its original axial orientation following formation of thedistal segments 198 such as by laser cutting from the tubular wall. - The
occlusion member 11 is provided with aproximal zone 212 on each of thespokes 17.Proximal zone 212 has an enhanced degree of flexibility, to accommodate the fit between theocclusion member 11 and the wall of the left atrial appendage.Proximal section 212 may be formed by reducing the cross sectional area of each of thespokes 17, which may be provided with a wave pattern as illustrated. - Each of the
spokes 17 terminates in aproximal point 214.Proximal point 214 may be contained within layers of thebarrier 15, or may extend through or beyond thebarrier 15 such as to engage adjacent tissue and assist in retaining theocclusion device 10 at the deployment site. - Referring to
Figures 5 and 6 , a further variation on theocclusion device 10 illustrated inFigures 1 and 2 is provided. Theocclusion device 10 is provided with aproximal face 216 on theocclusion member 11, instead of the open and proximally concave face on the embodiment ofFigures 1 and 2 . Theproximal face 216 is formed by providing aproximal spoke 218 which connects at an apex 220 to some or all of thedistal spokes 17. The proximal spoke 218, andcorresponding apex 220 and distal spoke 17 may be an integral structure, such as a single ribbon or wire, or element cut from a tube stock as has been discussed. -
Proximal spokes 218 are each attached to ahub 222 at theproximal end 192 of theocclusion device 10. Thebarrier 15 may surround either the proximal face or the distal face or both on theocclusion member 11. In general, provision of aproximal spoke 218 connected by an apex 220 to adistal spoke 17 provides a greater radial force than adistal spoke 17 alone, which will provide an increased resistance to compression if theocclusion member 11 is positioned with the LAA. - Referring to
Figures 7-12 , alternate structures of the occlusion device. In general, theocclusion device 10 comprises an occluding member but does not include a distinct stabilizing member as has been illustrated in connection with previous example. Any of the example previously disclosed herein may also be constructed using the occluding member only, and omitting the stabilizing member as will be apparent to those of skill in the art in view of the disclosure herein. - The occluding
device 10 comprises aproximal end 192, adistal end 190, and a longitudinal axis extending therebetween. A plurality ofsupports 228 extend between aproximal hub 222 and adistal hub 191. At least two or threesupports 228 are provided, and preferably at least about ten. In one embodiment, sixteensupports 228 are provided. However, the precise number ofsupports 228 can be modified, depending upon the desired physical properties of theocclusion device 10. - Each
support 228 comprises aproximal spoke portion 218, adistal spoke portion 17, and an apex 220 as has been discussed. Each of the proximal spokeportion 218,distal spoke portion 17 andapex 220 may be a region on anintegral support 228, such as a continuous rib or frame member which extends in a generally curved configuration as illustrated with a concavity facing towards the longitudinal axis of theocclusion device 10. Thus, no distinct point or hinge atapex 220 is necessarily provided. - At least some of the
supports 228, and, preferably, eachsupport 228, is provided with one or two ormore barbs 195. In the illustrated configuration, theocclusion device 10 is in its enlarged orientation, such as for occluding a left atrial appendage or other body cavity or lumen. In this orientation, each of thebarbs 195 projects generally radially outwardly from the longitudinal axis, and is inclined in the proximal direction. One or more barbs may also be inclined distally, as is discussed elsewhere herein. In an embodiment where thebarbs 195 andcorresponding support 228 are cut from a single ribbon, sheet or tube stock, thebarb 195 will incline radially outwardly at approximately a tangent to the curve formed by thesupport 228. - The
occlusion device 10 constructed from the frame illustrated inFigure 7 may be constructed in any of a variety of ways, as will become apparent to those of skill in the art in view of the disclosure herein. In one method, theocclusion device 10 is constructed by laser cutting a piece of tube stock to provide a plurality of axially extending slots in-betweenadjacent supports 228. Similarly, eachbarb 195 can be laser cut from thecorresponding support 228 or space in-betweenadjacent supports 228. The generally axially extending slots which separateadjacent supports 228 end a sufficient distance from each of theproximal end 192 anddistal end 190 to leave aproximal hub 222 and adistal hub 191 to which each of thesupports 228 will attach. In this manner, an integral cage structure may be formed. Alternatively, each of the components of the cage structure may be separately formed and attached together such as through soldering, brazing, heat bonding, adhesives, and other fastening techniques which are known in the art. A further method of manufacturing theocclusion device 10 is to laser cut a slot pattern on a flat sheet of appropriate material, such as a flexible metal or polymer, as has been discussed in connection with previous embodiments. The flat sheet may thereafter be rolled about an axis and opposing edges bonded together to form a tubular structure. - The
apex portion 220 which carries thebarb 195 may be advanced from a low profile orientation in which each of thesupports 228 extend generally parallel to the longitudinal axis, to an implanted orientation as illustrated, in which the apex 220 and thebarb 195 are positioned radially outwardly from the longitudinal axis. Thesupport 228 may be biased towards the enlarged orientation, or may be advanced to the enlarged orientation under positive force following positioning within the tubular anatomical structure, in any of a variety of manners. - For an example of enlarging under positive force, referring to
Figure 8 , aninflatable balloon 230 is positioned within theocclusion device 10.Inflatable balloon 230 is connected by way of aremovable coupling 232 to aninflation catheter 234.Inflation catheter 234 is provided with an inflation lumen for providing communication between aninflation media source 236 outside of the patient and theballoon 230. Following positioning within the target body lumen, theballoon 230 is inflated, thereby engagingbarbs 195 with the surrounding tissue. Theinflation catheter 234 is thereafter removed, by decoupling theremovable coupling 232, and theinflation catheter 234 is thereafter removed. Theballoon 230 may be either left in place within theocclusion device 10, or deflated and removed by theinflation catheter 234. - In an alternate example, the
supports 228 are radially enlarged such as through the use of adeployment catheter 238. SeeFIG. 9 .Deployment catheter 238 comprises a lumen for movably receiving a deployment element such as aflexible line 240.Deployment line 240 extends in aloop 244 formed by an aperture orslip knot 242. As will be apparent fromFigure 9 , proximal retraction on thedeployment line 240 while resisting proximal movement ofproximal hub 222 such as by using the distal end of thecatheter 238 will cause thedistal hub 191 to be drawn towards theproximal hub 222, thereby radially enlarging the cross-sectional area of theocclusion device 10. Depending upon the material utilized for theocclusion device 10, thesupports 228 will retain the radially enlarged orientation by elastic deformation, or may be retained in the enlarged orientation such as by securing theslip knot 242 immovably to thedeployment line 240 at the fully radially enlarged orientation. This may be accomplished in any of a variety of ways, using additional knots, clips, adhesives, or other techniques known in the art. - A variety of alternative structures may be utilized, to open or enlarge the
occlusion device 10 under positive force. For example, Referring toFIG. 9 , apullwire 240 may be removably attached to thedistal hub 191 or other distal point of attachment on theocclusion device 10. Proximal retraction of thepullwire 240 while resisting proximal motion of theproximal hub 222 such as by using the distal end of thecatheter 238 will cause enlargement of theocclusion device 10 as has been discussed. Thepullwire 240 may then be locked with respect to theproximal hub 222 and severed or otherwise detached to enable removal of thedeployment catheter 238 and proximal extension of thepullwire 240. Locking of the pullwire with respect to theproximal hub 222 may be accomplished in any of a variety of ways, such as by using interference fit or friction fit structures, adhesives, a knot or other technique depending upon the desired catheter design. - Referring to
Figures 10 and 11 , theocclusion device 10 may be provided with abarrier 15 such as a mesh or fabric as has been previously discussed.Barrier 15 may be provided on only one hemisphere such asproximal face 216, or may be carried by theentire occlusion device 10 fromproximal end 192 todistal end 190. The barrier may be secured to the radially inwardly facing surface of thesupports 228, as illustrated inFigure 11 , or may be provided on the radially outwardly facing surfaces ofsupports 228, or both. - A further example of the
occlusion device 10 is illustrated inFigure 12 , in which the apex 220 is elongated in an axial direction to provide additional contact area between theocclusion device 10 and the wall of the tubular structure. In this example, one or two or three ormore anchors 195 may be provided on eachsupport 228, depending upon the desired clinical performance. Theocclusion device 10 illustrated inFigure 12 may also be provided with any of a variety of other features discussed herein, such as a partial orcomplete barrier 15. In addition, theocclusion device 10 illustrated inFigure 12 may be enlarged using any of the techniques disclosed elsewhere herein. - Referring to
FIG. 17 . An adjustableimplant deployment system 300 comprises generally acatheter 302 for placing adetachable implant 304 within a body cavity or lumen, as has been discussed. Thecatheter 302 comprises an elongate flexibletubular body 306, extending between aproximal end 308 and adistal end 310. The catheter is shown in highly schematic form, for the purpose of illustrating the functional aspects thereof. The catheter body will have a sufficient length and diameter to permit percutaneous entry into the vascular system, and transluminal advancement through the vascular system to the desired deployment site. For example, in an embodiment intended for access at the femoral artery and deployment within the left atrial appendage, thecatheter 302 will have a length within the range of from about 50 cm to about 150 cm, and a diameter of generally no more than about 15 French. Further dimensions and physical characteristics of catheters for navigation to particular sites within the body are well understood in the art and will not be further described herein. - The
tubular body 306 is further provided with ahandle 309 generally on theproximal end 308 of thecatheter 302. Thehandle 309 permits manipulation of the various aspects of theimplant deployment system 300, as will be discussed below. Handle 309 may be manufactured in any of a variety of ways, typically by injection molding or otherwise forming a handpiece for single-hand operation, using materials and construction techniques well known in the medical device arts. - The
implant 304 may be in the form of any of those described previously herein, as modified below. In general, the implant is movable from a reduced crossing profile to an enlarged crossing profile, such that it may be positioned within a body structure and advanced from its reduced to its enlarged crossing profile to obstruct bloodflow or perform other functions while anchored therein. Theimplant 304 may be biased in the direction of the enlarged crossing profile, may be neutrally biased or may be biased in the direction of the reduced crossing profile. Any modifications to the device and deployment system to accommodate these various aspects of theimplant 304 may be readily accomplished by those of skill in the art in view of the disclosure herein. - In the illustrated example, the
distal end 314 of theimplant 304 is provided with animplant plug 316.Implant plug 316 provides a stoppingsurface 317 for contacting an axiallymovable core 312. Thecore 312 extends axially throughout the length of thecatheter body 302, and is attached at its proximal end to a core control 332 on thehandle 309. - The
core 312 may comprise any of a variety of structures which has sufficient lateral flexibility to permit navigation of the vascular system, and sufficient axial column strength to enable reduction of theimplant 304 to its reduced crossing profile. Any of a variety of structures such as hypotube, solid core wire, "bottomed out" coil spring structures, or combinations thereof may be used, depending upon the desired performance of the finished device. In one embodiment, thecore 312 comprises stainless steel tubing. - The distal end of
core 312 is positioned within a recess orlumen 322 defined by a proximally extendingguide tube 320. In the illustrated embodiment, theguide tube 320 is a section of tubing such as metal hypotube, which is attached at thedistal end 314 of the implant and extends proximally within theimplant 304. Theguide tube 320 preferably extends a sufficient distance in the proximal direction to inhibit buckling or prolapse of thecore 312 when distal pressure is applied to the core control 332 to reduce the profile of theimplant 304. However, theguide tube 320 should not extend proximally a sufficient distance to interfere with the opening of theimplant 304. - As will be appreciated by reference to
Figure 17 , theguide tube 320 may operate as a limit on distal axial advancement of theproximal end 324 ofimplant 304. Thus, theguide tube 320 preferably does not extend sufficiently far proximally from thedistal end 314 to interfere with optimal opening of theimplant 304. The specific dimensions are therefore relative, and will be optimized to suit a particular intended application. In one example, theimplant 304 has an implanted outside diameter within the range of from about 5 mm to about 45 mm, and an axial implanted length within the range of from about 5 mm to about 45 mm. Theguide tube 320 has an overall length of about 3 mm to about 35 mm, and an outside diameter of about 0.095 inches. - An
alternate guide tube 320 is schematically illustrated inFigure 18 . In this configuration, theguide tube 320 comprises a plurality oftubular segments 321 spaced apart by an interveningspace 323. This allows increased flexibility of theguide tube 320, which may be desirable during the implantation step, while retaining the ability of theguide tube 320 to maintain linearity of thecore 312 while under axial pressure. Although threesegments 321 are illustrated inFigure 18 , as many as 10 or 20 ormore segments 321 may be desirable depending upon the desired flexibility of the resulting implant. - Each adjacent pair of
segments 321 may be joined, by ahinge element 325 which permits lateral flexibility. In the illustrated example, thehinge element 325 comprises an axially extending strip or spine, which provides column strength along a first side of theguide tube 320. Theguide tube 320 may therefore be curved by compressing a second side of theguide tube 320 which is generally offset from thespine 325 by about 180°. A limit on the amount of curvature may be set by adjusting the axial length of thespace 323 betweenadjacent segments 321. In an example havingaxial spines 325, eachaxial spine 325 may be rotationally offset from the next adjacentaxial spine 325 to enable flexibility of theoverall guide tube 320 throughout a 360° angular range of motion. - Alternatively, the flexible hinge point between each
adjacent segment 321 may be provided by cutting a spiral groove or plurality of parallel grooves in a tubular element in between what will then become each adjacent pair ofsegments 321. In this manner, eachtubular element 321 will be separated by an integral spring like structure, which can permit flexibility. As a further alternative, the entire length of theguide tube 320 may comprise a spring. Each of the forgoing examples may be readily constructed by laser cutting or other cutting from a piece of tube stock, to produce a onepiece guide tube 320. Alternatively, theguide tube 320 may be assembled from separate components and fabricated together using any of a variety of bonding techniques which are appropriate for the construction material selected for thetube 320. - Various
distal end 314 constructions may be utilized, as will be apparent to those of skill in the art in view of the disclosure herein. In the illustrated example, thedistal implant plug 316 extends within theimplant 304 and is attached to the distal end of theguide tube 320. Theimplant plug 316 may be secured to theguide tube 320 andimplant 304 in any of a variety of ways, depending upon the various construction materials. For example, any of a variety of metal bonding techniques such as a welding, brazing, interference fit such as threaded fit or snap fit, may be utilized. Alternatively, any of a variety of bonding techniques for dissimilar materials may be utilized, such as adhesives, and various molding techniques. In one construction, theimplant plug 316 comprises a molded polyethylene cap, and is held in place utilizing adistal cross pin 318 which extends through theimplant 304, theguide tube 320 and theimplant plug 316 to provide a secure fit against axial displacement. - The
proximal end 324 of theimplant 304 is provided with areleasable lock 326 for attachment to a release element such aspull wire 328. Pullwire 328 extends proximally throughout the length of thetubular body 306 to a proximalpull wire control 330 on thehandle 309. - As used herein, the term pull wire is intended to include any of a wide variety of structures which are capable of transmitting axial tension or compression such as a pushing or pulling force with or without rotation from the
proximal end 308 to thedistal end 310 of thecatheter 302. Thus, monofilament or multifilament metal or polymeric rods or wires, woven or braided structures may be utilized. Alternatively, tubular elements such as a concentric tube positioned within the outertubular body 306 may also be used as will be apparent to those of skill in the art. - In the illustrated example, the
pull wire 328 is releasably connected to theproximal end 324 of theimplant 304. This permits proximal advancement of the proximal end of theimplant 304, which cooperates with a distal retention force provided by thecore 312 against the distal end of the implant to axially elongate theimplant 304 thereby reducing it from its implanted configuration to its reduced profile for implantation. The proximal end of thepull wire 328 may be connected to any of a variety of pull wire controls 330, including rotational knobs, levers and slider switches, depending upon the design preference. - The
proximal end 324 of theimplant 304 is thus preferably provided with areleasable lock 326 for attachment of thepullwire 328 to the deployment catheter. In the illustrated embodiment, the releasable lock is formed by advancing the pullwire distally around across pin 329, and providing an eye or loop which extends around thecore 312. As long as thecore 312 is in position within theimplant 304, proximal retraction of thepullwire 328 will advance theproximal end 324 of theimplant 304 in a proximal direction. SeeFigure 17A . However, following deployment, proximal retraction of the core 312 such as by manipulation of the core control 332 will pull the distal end of the core 312 through the loop on the distal end of thepullwire 328. Thepullwire 328 may then be freely proximally removed from theimplant 304, thereby enabling detachment of theimplant 304 from thedeployment system 300 within a treatment site. SeeFigure 17B . - The
implant deployment system 300 thus permits theimplant 304 to be maintained in a low crossing profile configuration, to enable transluminal navigation to a deployment site. Following positioning at or about the desired deployment site, proximal retraction of thecore 312 enables theimplant 304 to radially enlarge under its own bias to fit the surrounding tissue structure. Alternatively, the implant can be enlarged under positive force, such as by inflation of a balloon or by a mechanical mechanism as is discussed elsewhere herein. Once the clinician is satisfied with the position of theimplant 304, such as by injection of dye and visualization using conventional techniques, thecore 312 is proximally retracted thereby releasing thelock 326 and enabling detachment of theimplant 304 from thedeployment system 300. - If, however, visualization reveals that the
implant 304 is not at the location desired by the clinician, proximal retraction of thepull wire 328 with respect to thecore 312 will radially reduce the diameter of theimplant 304, thereby enabling repositioning of theimplant 304 at the desired site. Thus, the present invention permits theimplant 304 to be enlarged or reduced by the clinician to permit repositioning and/or removal of theimplant 304 as may be desired. - The implant is radially enlarged or reduced by rotating a torque element extending throughout the deployment catheter. Referring to
Figure 19 , the elongate flexibletubular body 306 of thedeployment catheter 302 includes arotatable torque rod 340 extending axially therethrough. The proximal end of thetorque rod 340 may be connected at a proximal manifold to a manual rotation device such as a hand crank, thumb wheel, rotatable knob or the like. Alternatively, thetorque rod 340 may be connected to a power driven source of rotational energy such as a motor drive or air turbine. - The distal end of the
torque rod 340 is integral with or is connected to arotatable core 342 which extends axially through theimplant 304. Adistal end 344 of therotatable core 342 is positioned within acavity 322 as has been discussed. - The terms torque rod or torque element are intended to include any of a wide variety of structures which are capable of transmitting a rotational torque throughout the length of a catheter body. For example, solid core elements such as stainless steel, nitinol or other nickel titanium alloys, or polymeric materials may be utilized. In an embodiment intended for implantation over a guide-wire, the
torque rod 340 is preferably provided with an axially extending central guidewire lumen. This may be accomplished by constructing thetorque rod 340 from a section of hypodermic needle tubing, having an inside diameter of from about 0,0025 cm to 0,013 cm (0.001 inches to about 0.005 inches) or more greater than the outside diameter of the intended guidewire.Tubular torque rods 340 may also be fabricated or constructed utilizing any of a wide variety of polymeric constructions which include woven or braided reinforcing layers in the wall. Torque transmitting tubes and their methods of construction are well understood in the intracranial access and rotational atherectomy catheter arts, among others, and are not described in greater detail herein. Use of atubular torque rod 340 also provides a convenient infusion lumen for injection of contrast media within theimplant 304, such as through aport 343. - The
proximal end 324 of theimplant 304 is provided with a threadedaperture 346 through which thecore 342 is threadably engaged. As will be appreciated by those of skill in the art in view of the disclosure herein, rotation of the threadedcore 342 in a first direction relative to theproximal end 324 of theimplant 304 will cause therotatable core 342 to advance distally. This distal advancement will result in an axial elongation and radial reduction of theimplantable device 304. Rotation of therotatable core 342 in a reverse direction will cause a proximal retraction of therotatable core 342, thus enabling a radial enlargement and axial shortening of theimplantable device 304. - The
deployment catheter 302 is further provided with anantirotation lock 348 between adistal end 350 of thetubular body 306 and theproximal end 324 of theimplant 304. In general, therotational lock 348 may be conveniently provided by cooperation between afirst surface 352 on thedistal end 350 of thedeployment catheter 302, which engages a second surface 354 on theproximal end 324 of theimplantable device 304, to rotationally link thedeployment catheter 302 and theimplantable device 304. Any of a variety of complementary surface structures may be provided, such as an axial extension on one of the first and second surfaces for coupling with a corresponding recess on the other of the first and second surfaces. Such extensions and recesses may be positioned laterally offset from the axis of the catheter. Alternatively, they may be provided on the longitudinal axis with any of a variety of axially releasable anti-rotational couplings having at least one flat such as a hexagonal or other multifaceted cross sectional configuration. - As schematically illustrated in
Figure 19 , one ormore projections 356 on thefirst surface 352 may engage acorresponding recess 358 on the second surface 354. Any of a variety of alternative complementary surface structures may also be provided, as will be apparent to those of skill in the art in view of the disclosure herein. For example, referring toFigure 19A , theprojection 356 is in the form of an axially extending pin for engaging acomplimentary recess 358 on theproximal end 324 of theimplant 304.Figure 19B illustrates anaxially extending spline 356 for receipt within a complimentary axially extendingrecess 358. The various pin, spline and other structures may be reversed between the distal end oftubular body 306 and theproximal end 324 of theimplant 304 as will be apparent to those of skill in the art in view of the disclosure herein. - Upon placement of the
implantable device 304 at the desired implantation site, thetorque rod 340 is rotated in a direction that produces an axial proximal retraction. This allows radial enlargement of the radially outwardly biasedimplantable device 304 at the implantation site. Continued rotation of thetorque rod 340 will cause the threadedcore 342 to exit proximally through the threadedaperture 346. At that point, thedeployment catheter 302 may be proximally retracted from the patient, leaving the implanteddevice 304 in place. - By modification of the decoupling mechanism to allow the
core 342 to be decoupled from thetorque rod 340, therotatable core 342 may be left within theimplantable device 304, as may be desired depending upon the intended deployment mechanism. For example, the distal end of thecore 342 may be rotatably locked within theend cap 326, such as by including complimentary radially outwardly or inwardly extending flanges and grooves on the distal end of thecore 342 and inside surface of thecavity 322. In this manner, proximal retraction of thecore 342 by rotation thereof relative to theimplantable device 304 will pull theend cap 326 in a proximal direction under positive force. This may be desirable as a supplement to or instead of a radially enlarging bias built into theimplantable device 304. - A positive expansion force may also be achieved in the embodiment illustrated in
FIG. 21 . In the illustrated example, afirst coil 402 is fixedly attached to theproximal end 324 of the implant. Asecond coil 404 is rotatably locked within theend cap 326, such as by complimentary radially inwardly extending tabs orflanges 407 on the inside surface of thecavity 322, and radially inwardly extending groove or radially outwardly extendingsurface 408 on the outside surface of the distal end of the second coil. Alternatively, thesecond coil 404 can be rotatably locked within theend cap 326 by complimentary radially outwardly extending flanges on the outside surface of the distal end of the second coil, and grooves on the inside surface of the cavity. - A
torque rod 340 passes through anaperture 400 in theproximal end 324 of theimplant 304, through thefirst coil 402, through thesecond coil 404, and into a fitting 412 in the distal end of the second coil. As illustrated inFigures 21B and 21C , thedistal end 414 of thetorque rod 340 has an exterior cross-sectional profile that corresponds to the interior cross-sectional profile of the fitting 412. The torque rod is able to slide freely longitudinally within the fitting 412 and is able to apply a rotational torque to the fitting. - As illustrated in
Fig. 21C , the interior lumen of the fitting 412 may have an oval cross section. As illustrated inFig. 21B , the exterior of the distal section of the distal end of thetorque rod 414 preferably has a complimentary cross section. The complimentary cross sections could also be any other shape, such as a triangle, square, hexagon, ellipse, circle with one or more complimentary intruding and extruding pins, splines, flanges, grooves or other structures disclosed elsewhere herein, or any other regular or irregular polygon that would allow thetorque rod 340 to apply a rotational torque to the fitting 412. As illustrated inFigures 22A and22B , applying a rotational force to the torque rod causes thesecond coil 404 to engage thefirst coil 402. This engagement allows rotation of the torque rod in a first direction to cause axial compression and radial expansion of theimplant 304. This allows for precise fitting of the implant within the cavity. - The
first coil 402 and thesecond coil 404, together with the adjacent tubular support may be manufactured in any of a variety of ways which will be understood by those of skill in the art. In one example, a stainless steel tube stock having an inside diameter of about 0,10 cm (0.040 inches) and an outside diameter of about 0,16 cm (0.065) inches is laser-cut according to conventional techniques to form the spiral ribbon. In one example, the width of the ribbon in the axial direction is about 0,035 cm (0.014 inches), and the spacing between adjacent windings of the ribbon, measured in the axial direction, is about 0,05 cm (0.020 inches). The dimensions may be varied widely, depending upon the intended clinical application, construction materials, desired flexibility, and other choices which can be optimized by those of skill in the art in view of the disclosure herein. - In the illustrated example, the
first coil 402 andsecond coil 404 have an X approximately equivalent diameter and complimentary structure to allow threadable engagement as illustrated, for example, inFigure 22A . Alternatively, one of thefirst coil 402 orsecond coil 404 may be replaced by a tubular or other element which is dimensioned to reside adjacent the radially inwardly facing surface of thecomplimentary coil coil first coil 402 and have an outside diameter of slightly less than the inside diameter of thesecond coil 404. The tubular body is provided with one or more radially outwardly extending post or flanges, to engage the spiral groove in thesecond coil 404. Operation of the device is similar to that described previously, such that rotation of one component with respect to the other will cause an axial compression or expansion across the operating range. - In another example, illustrated in
Figure 23 , thefirst coil 402 is rotatably locked within theproximal end 324 of the implant, and thesecond coil 404, is fixedly attached to theend cap 326. In this example, thetorque rod 340 passes through anaperture 400 in theproximal end 324 of theimplant 304, and into a fitting 412 in the proximal end of thefirst coil 402. As described above in the previous example, with respect to the rotatably attachedsecond coil 404, in this embodiment thefirst coil 402 is rotatably locked within theproximal end 324 of the implant by any conventional means known to those of ordinary skill in the art, such as by inwardly extendingradial flanges 407 andcomplimentary grooves 408 on the outer surface of the coil. - As illustrated in
Figures 24C and 24D , thedistal end 414 of thetorque rod 340 has an exterior cross-sectional profile that corresponds to the interior cross-sectional profile of the fitting 412, as described above in the previous embodiment. As illustrated inFigures 24A and24B , applying a rotational force to the torque rod causes thefirst coil 402 to engage thesecond coil 404. This engagement causes axial compression and radial expansion of theimplant 304. This allows for precise fitting of the implant within the cavity as described above. - In both of the examples described above, applying a rotational force to the torque rod in the opposite direction causes the first and second coils to axially elongate, and then disengage. Tins results in an axial expansion and radial compression of the
implant 304. This allows the implant to be repositioned within, or removed from, the cavity. In other embodiments, the first and second coils may be any type of threadably engageable first and second members as are conventionally used in the art. The optimum type of threadable engagement can be determined for any particular application and for any particular material or combination of materials through routine experimentation by one or ordinary skill in the art based on the disclosures herein. - Thus, for example, the example of
Figure 19 can be modified to provide expansion under positive force by providing a rotatable engagement between thedistal end 344 ofrotatable core 342 and the surface ofcavity 322. This will allow rotation of the core 342 to either radially expand or contract the implant. Rotatable screw mechanisms may, however, reduce the flexibility of the device compared to the examples ofFigures 21-24 , which may inhibit transluminal navigation. - Any of the variety of alternate configurations may be utilized, to provide a positive expansion force on the implant as will be apparent to those of skill in the art in view of the disclosure herein. For example, the distal end of the implant may be connected to a pull string or pull wire, which extends proximally throughout the length of the catheter. Proximal retraction on the pull wire will axially proximally advance the distal end of the implant, thereby providing positive radial expansion force. Any of a variety of releasable ratchet or other engagement structures may be provided within the implant, for retaining the implant in the expanded configuration. The pull wire may be released, and proximally retracted from the catheter in a manner similar to that discussed in connection with the embodiment of
Figure 17 . In the simplest example, the pull wire simply loops around a post or through an eye connected mechanically to the distal end of the implant. Both ends of the pull wire extend all the way to the proximal end of the device. One end of the pull wire may be released from its attachment to the proximal end of the device, and the second end of the pull wire may be proximally retracted, to remove the wire from the device following active expansion at the treatment site. - As disclosed elsewhere herein, the above described axial expansion may be optionally combined with an implant that is positively, negatively or neutrally biased toward expansion. The optimum combination of passive and active expansion can be determined for any particular application and for any particular material or combination of materials through routine experimentation by one or ordinary skill in the art based on the disclosures herein.
- Routine experimentation will demonstrate those limited circumstances under which certain disclosures and combinations thereof are not beneficial.
- In any of the occlusion devices described herein, one or more tissue engagement anchors may be provided, as has been discussed, for example, in connection with
anchors 195 in the embodiments ofFigures 9 - 12 . One or more anchors may also or alternatively be provided, extending distally along or substantially parallel to the longitudinal axis of the device. Preferably the longitudinally disposed anchors do not extend beyond thedistal end 190 of the occlusion device during transluminal navigation to the deployment site. After theocclusion device 10 is deployed, one or more distal anchors are extended beyond thedistal end 190 of the occlusion device in order to secure the occlusion device to the surrounding tissue. Alternatively, the distal anchor or anchors may be extended beyond thedistal tip 190 before or during deployment. Extending the distal anchor or anchors before or during deployment may assist in deploying or positioning the device. The anchors may have sharpened distal tips to facilitate penetration into the surrounding tissue. - In the embodiment illustrated in
Figure 25 , theanchor 420 has a distaltissue engaging section 422. Preferably thedistal section 422 is laser-cut from tube stock to form a helix with a circular cross section (corkscrew) with a sharpeneddistal tip 424. The helicaldistal section 422 is threadably engaged with thedistal end 190 of the occlusion device via an engagingmember 430 such as a complementary thread or projection. Abridge 432 may be provided between at least two of the coils of thedistal section 422. Thebridge 432 places a rotational limit on the extent to which the anchor can advance toward the proximal end of the occlusion device. This prevents the anchor from completely disengaging or "unscrewing" from thedistal end 190 of the occlusion device. Preferably, thebridge 432 is between the second and third helical coils from the sharpeneddistal tip 424. In other embodiments, thebridge 432 will connect other helical coils depending on the specific application. Alternative limiting structures may also be used, to limit the proximal and/or distal axial travel of thetissue engaging section 422 with respect to thedistal end 190 of the occlusion device. - The
proximal section 426 of theanchor 420 has a central lumen orcavity 428. As illustrated inFig. 25A thecavity 428 preferably has a non-round cross section. Atorque rod 340 has adistal end 414. As illustrated inFig. 25B , the exterior of the distal end of thetorque rod 414 preferably has a complimentary cross section to the interior cross section of thecavity 428. In other embodiments, the complimentary cross sections can be other shapes, such as a triangle, square, hexagon, ellipse, circle with one or more complimentary intruding and extruding pins, splines, flanges, grooves or other structures disclosed elsewhere herein, or any other regular or irregular polygon that allows thetorque rod 340 to apply a rotational torque to theanchor 420. - As illustrated in
Figure 26 , applying a rotational force to thetorque rod 340 causes the helicaldistal section 422 to threadably engage the engagingmember 430. The causes the sharpenedtip 424 to advance distally beyond the distal tip of theocclusion device 191. The sharpenedtip 424 facilitates the penetration of the helicaldistal section 422 into thebody tissue 434. When the helical distal section is sufficiently engaged with the body tissue, thetorque rod 340 may be retracted proximally and removed from the device. Preferably, theanchor 420 and thetorque rod 340 both contain a lumen that allows for the introduction of visualizable media on either side of the occlusion device (not illustrated). Thetorque rod 340 can be reinserted distally into the anchor and the opposite rotational torque applied to disengage the coils from the tissue. - In the example illustrated in
Figure 27A theanchor 420 is a biocompatible wire or ribbon, preferably made of stainless steel, nitinol or elgiloy. Thedistal section 440 of the anchor is biased to form a curve or hook and thedistal tip 442 is sharpened to facilitate tissue penetration. Preferably thedistal section 440 of the anchor is biased to form at least about a 60 degree and as much as about a 300 degree curve or more. In one example thedistal section 440 is biased to form a curve of about 180 degrees. During deployment of the occlusion device, theanchor 420 resides in a substantially linear position within alumen 444 in an active anchoring device and does not extend beyond thedistal tip 191 of the occlusion device. Thelumen 444 is disposed substantially along the longitudinal axis of the occlusion device and may be disposed concentrically, next to, or substantially parallel to any other longitudinally disposed structures, such as the torque rod or collapsing shaft disclosed herein. - As illustrated in 27B, the
anchor 420 is advanced distally throughlumen 444, and through alumen 446 in thedistal tip 190 of the occlusion device. Theanchor 420 may be advanced by any of the conventional means known to those of ordinary skill in the art to maneuver an object at the distal end of a catheter, such as those described elsewhere herein. Preferably, the proximal section of theanchor 420 is releasably in contact with and/or attached to the distal end of adeployment shaft 456. The proximal end of the deployment shaft has an appropriate control, such as a button, knob, lever or handle. Theanchor 420 may also be advanced by a biasing structure such as a spring or coil. - As the
distal section 440 of the anchor advances beyond the distal tip of the occlusion device, the sharpdistal end 442 of the anchor engages the tissue. As illustrated inFigure 27C , as thedistal end 442 is further advanced, the bias of the distal section of the anchor causes the sharpdistal tip 442 to travel along an arcuate pathway through the tissue and optionally toward ananchor capture structure 448. Theanchor capture structure 448 may be a second lumen or recess in the distal tip of the occlusion device. Thedistal section 420 of the anchor thereby forms a loop, or hook, through the tissue. As will be appreciated by one of ordinary skill in the art, theanchor capture structure 448 need not be a second lumen, but can be any structure capable of securing thedistal tip 442 of the anchor. In particular embodiments, depending on the desired application, selected material, and shape of theanchor 420, theanchor capture structure 448 may be unnecessary. The optimal anchor configuration, if any, can be determined based on routine experimentation by one of ordinary skill in the art based on the disclosures herein. After the anchor is positioned in the tissue, thedeployment shaft 456 is detached from theanchor 420 at release point 457. - In the example illustrated in
Figure 28A , theanchor 420 is a coil or spring of wire or ribbon, preferably made of stainless steel, nitinol or elgiloy. Theanchor 420 may reside within either an axiallymovable support tube 450 or within a lumen extending through thedistal tip 191. Thesupport tube 450 or the lumen extends along the longitudinal axis of the occlusion device and may be disposed concentrically, next to, or substantially parallel to any other longitudinally disposed structures, such as the torque rod or collapsing shaft disclosed herein. Thedistal tip 452 of thesupport tube 450 is sharpened to facilitate tissue penetration. In one example, the support tube comprises a hypodermic needle tube having an OD of about 0,14 cm (0.056 inches) and an ID of about 0,12 cm (0.050 inches). - As illustrated in
Figure 28B , after deployment of the occlusion device, thesupport tube 450 is advanced distally through alumen 454 in thedistal dip 191 of the occlusion device. Thesupport tube 450 may be advanced by any of the conventional means known to those of ordinary skill in the art to maneuver an object at the distal end of a catheter, such as an axially movable push wire, or by extending the hypotube proximally throughout the length of the catheter body to a proximal slider switch or other control. Thesupport tube 450 may be a distal section of an axiallymovable deployment shaft 456. The proximal end of the deployment shaft has an appropriate control such as a knob, lever or handle. Thesupport tube 450 may also be advanced by a biasing structure such as a spring or coil. - Advancing the
deployment shaft 456 distally advances thesupport tube 450 beyond the distal tip of the occlusion device. The sharpdistal tip 452 is advanced until it penetrates the tissue. As illustrated inFigure 28C , when thesupport tube 450 is advanced sufficiently into the tissue, theanchor 420 may be held axially stationary with respect to the tissue and thesupport tube 450 may be proximally withdrawn until theanchor 420 engages the tissue. Moving or restraining theanchor 420 with respect to thesupport tube 450 may be accomplished by acontrol wire 460 disposed within the lumen of the deployment shaft. The distal end of thecontrol wire 460 may be releasably connected to theanchor 420, or simply abut the proximal end of the anchor, while the proximal end of the control wire has appropriate control means as disclosed elsewhere herein. The anchor may also be rotated into the distal tissue, particularly in an example which omits aseparate support tube 450. When theanchor 420 has sufficiently engaged the tissue, either by advancing theanchor 420, withdrawing thesupport tube 450, or by a combination of the two, thesupport tube 450 is withdrawn from the occlusion device. Optionally, the proximal portion of theanchor 420 engages a locking pin orflange 458 in thelumen 454 to assist in securing the occlusion device to the tissue. - In the example illustrated in
FIG. 19 , or any other of the deployment and/or removal catheters described herein, the distal end of thetubular body 306 may be provided with a zone or point of enhanced lateral flexibility. This may be desirable in order allow the implant to seat in the optimal orientation within the left atrial appendage, and not be restrained by a lack of flexibility in thetubular body 306. This may be accomplished in any of a variety of ways, such as providing the distal most one or two or three centimeters or more of thetubular body 306 with a spring coil configuration. In this manner, the distal end of thetubular body 306 will be sufficiently flexible to allow theimplant 304 to properly seat within the LAA. This distal flex zone on thetubular body 306 may be provided in any of a variety of ways, such as by cutting a spiral slot in the distal end of thetubular body 306 using laser cutting or other cutting techniques. The components within thetubular body 306 such astorque rod 340 may similarly be provided with a zone of enhanced flexibility in the distal region of thetubular body 306. - The
implantable device 304 may also be retrieved and removed from the body in accordance with a further aspect of the present invention. One manner of retrieval and removal will be understood in connection withFigures 20 through 20c . Referring toFigure 20 , a previously implanteddevice 304 is illustrated as releasably coupled to the distal end of thetubular body 306, as has been previously discussed. Coupling may be accomplished by aligning thetubular body 306 with theproximal end 324 of the deployedimplant 304, under fluoroscopic visualization, and distally advancing arotatable core 342 through the threadedaperture 346. Threadable engagement between therotatable core 342 andaperture 346 may thereafter be achieved, and distal advancement ofcore 342 will axially elongate and radially reduce theimplant 304. - The
tubular body 306 is axially moveably positioned within an outer tubular delivery orretrieval catheter 360.Catheter 360 extends from a proximal end (not illustrated) to a distal end 362. The distal end 362 is preferably provided with a flared opening, such as by constructing a plurality ofpetals 364 for facilitating proximal retraction of theimplant 304 as will become apparent.Petals 364 may be constructed in a variety of ways, such as by providing axially extending slits in the distal end 362 of thedelivery catheter 360. In this manner, preferably at least about three, and generally at least about four or five or six petals or more will be provided on the distal end 362 of thedelivery catheter 360.Petals 364 manufactured in this manner would reside in a first plane, transverse to the longitudinal axis of thedelivery catheter 360, if each ofsuch petals 364 were inclined at 90 degrees to the longitudinal axis of thedelivery catheter 360. - In one application of the invention, a second layer of
petals 365 are provided, which would lie in a second, adjacent plane if thepetals 365 were inclined at 90 degrees to the longitudinal axis of thedelivery catheter 360. Preferably, the second plane ofpetals 365 is rotationally offset from the first plane ofpetals 364, such that thesecond petals 365 cover thespaces 367 formed between each adjacent pair ofpetals 365. The use of two or more layers of staggeredpetals implants 304, particularly when theimplant 304 carries a plurality of tissue anchors 195. - The
petals delivery catheter 360. This includes, for example, polyethylene, PET, PEEK, PEBAX, and others well known in the art. Thesecond petals 365 may be constructed in any of a variety of ways. In one convenient construction, a section of tubing which concentrically fits over thedelivery catheter 360 is provided with a plurality of axially extending slots in the same manner as discussed above. The tubing with a slotted distal end may be concentrically positioned on thecatheter 360, and rotated such that the space betweenadjacent petals 365 is offset from the space betweenadjacent petals 364. The hub of thepetals 365 may thereafter be bonded to thecatheter 360, such as by heat shrinking, adhesives, or other bonding techniques known in the art. - The removal sequence will be further understood by reference to
Figures 20a through 20c . Referring toFigure 20a , the radially reducedimplant 304 is proximally retracted part way into thedelivery catheter 360. This can be accomplished by proximally retracting thetubular body 306 and/or distally advancing thecatheter 360. As illustrated inFigure 20b , thetubular body 306 having theimplant 304 attached thereto is proximally retracted a sufficient distance to position the tissue anchors 195 within thepetals 364. The entire assembly of thetubular body 306, within thedelivery catheter 360 may then be proximally retracted within thetranseptal sheath 366 or other tubular body as illustrated inFigure 20c . The collapsedpetals 364 allow this to occur while preventing engagement of the tissue anchors 195 with the distal end of thetranseptal sheath 366 or body tissue. The entire assembly having theimplantable device 304 contained therein may thereafter be proximally withdrawn from or repositioned within the patient.
Claims (8)
- An implantable device, comprising:an implant (304) having a proximal end (324) and a distal end (314);a tissue engaging member (420) having a proximal end and a distal end (424, 442), wherein the tissue engaging member (420) is at least partially disposed within the implant (304) and the distal end (424, 442) of the tissue engaging member (420) is sufficiently sharp to penetrate tissue; wherein the distal end (424, 442) of the tissue engaging member (420) is moveable between a first position within the implant (304) and a second position extending beyond the distal end of the implant (304); anda control (340) having a proximal end and a distal end (414), wherein the distal end (414) of the control (340) is releasably connected to the tissue engaging member (420) and the distal end of the tissue engaging member (420) is extendable beyond the distal end (314) of the implant (304) by manipulation of the control (340), characterised in that the proximal end of the tissue engaging member (420) comprises a hollow tube, and the distal end of the control (340) is insertable within the proximal end of the tissue engaging member (420), such that the control (340) can freely move longitudinally within the tissue engaging member (420) and can apply rotational torque to the tissue engaging member (420) andwherein the tissue engaging member (420) comprises a helical coil.
- An implantable device as in Claim 1, wherein the tissue engaging member (420) threadingly engages the distal end (314) of the implant (304).
- An implantable device as in Claim 1, wherein the implant (304) comprises an expandable frame (14).
- An implantable device as in Claim 3, wherein the expandable frame (14) is self-expanding.
- An implantable device as in Claim 3, wherein the expandable frame (14) comprises a plurality of supports (228).
- An implantable device as in Claim 5, wherein the supports (228) extend between a proximal hub (222) and a distal hub (191).
- An implantable device as in Claim 1, wherein a longitudinal axis is defined between the proximal (324) and distal (314) ends of the implant (304), and the tissue engaging member (420) extends distally substantially parallel to the longitudinal axis.
- An implantable device as in Claim 1, wherein the implant (304) is sized for positioning within a left atrial appendage.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/426,107 US7597704B2 (en) | 2003-04-28 | 2003-04-28 | Left atrial appendage occlusion device with active expansion |
PCT/US2004/012319 WO2004096060A2 (en) | 2003-04-28 | 2004-04-22 | Left atrial appendage occlusion device with active expansion |
Publications (2)
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EP1620020A2 EP1620020A2 (en) | 2006-02-01 |
EP1620020B1 true EP1620020B1 (en) | 2010-09-08 |
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Application Number | Title | Priority Date | Filing Date |
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EP04750428A Expired - Lifetime EP1620020B1 (en) | 2003-04-28 | 2004-04-22 | Left atrial appendage occlusion device with active expansion |
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US (1) | US7597704B2 (en) |
EP (1) | EP1620020B1 (en) |
AT (1) | ATE480190T1 (en) |
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WO (1) | WO2004096060A2 (en) |
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US10667896B2 (en) | 2015-11-13 | 2020-06-02 | Cardiac Pacemakers, Inc. | Bioabsorbable left atrial appendage closure with endothelialization promoting surface |
US11234706B2 (en) | 2018-02-14 | 2022-02-01 | Boston Scientific Scimed, Inc. | Occlusive medical device |
Also Published As
Publication number | Publication date |
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DE602004029023D1 (en) | 2010-10-21 |
EP1620020A2 (en) | 2006-02-01 |
ATE480190T1 (en) | 2010-09-15 |
WO2004096060A3 (en) | 2005-01-20 |
US20040215230A1 (en) | 2004-10-28 |
WO2004096060A2 (en) | 2004-11-11 |
US7597704B2 (en) | 2009-10-06 |
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